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Most recent job postings at fluxus
via Lever
schedule_type: Full-time
To support its product development activities, Fluxus Inc. is seeking a highly motivated, interdisciplinary, product development research associate / technician / engineer with relevant, hands-on experience. She/He/They will be part of the System Integration team and will play a vital role in developing, testing, optimizing, and troubleshooting many aspects related to a novel diagnostics... technology platform.
She/He/They will work closely with
To support its product development activities, Fluxus Inc. is seeking a highly motivated, interdisciplinary, product development research associate / technician / engineer with relevant, hands-on experience. She/He/They will be part of the System Integration team and will play a vital role in developing, testing, optimizing, and troubleshooting many aspects related to a novel diagnostics... technology platform.
She/He/They will work closely with other Fluxus teams and will perform instrument development tasks related to novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. Activities will involve amongst others the testing, development and optimization of functional biochips, fluidic cartridges, and analytical instruments. The successful applicant will work within a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.
Principal Duties and Responsibilities
• Support diverse aspects related to the product development of biochip-based, optofluidic diagnostics platforms. Applies diversified knowledge of interdisciplinary knowledge to understand, test and optimize all aspects of the technology
• Development, optimization & testing of biochips, cartridges and instruments, in collaboration with other groups and external suppliers
• Provide support in preparing documentation
• Use Good Documentation Practices (GDP) while authoring Experimental summaries, DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations
• Process development and optimization related to biomolecular sensing
• Support all aspects of technology transfer to and from development partners
• Develop, test and execute QC procedures
• Process troubleshooting to determine root cause and find possible engineering solutions
Requirements
• M.S. Degree in bio-, mechanical-, electrical- or chemical engineering, chemistry or biochemistry, or related, technical discipline, with 2+ years hands-on R&D or engineering or product development experience
• Inquisitive, interdisciplinary mindset
• Extensive, hands-on experience working with and optimizing complex instrumentation
• Excellent organizational as well as English (verbal and written) communication skills
• Experienced in using diverse instruments such as – or similar to e.g. – analytical instrumentation, DAQ interfaces, UV-VIS spectrometer, scanning electron microscope (SEM)
• Good knowledge of data analysis methods including good knowledge of statistics
• Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic
• Ability and willingness to quickly learn and apply new skills, procedures and approaches
• Proven ability to work collaboratively in a team-based environment
• Proven ability to handle multiple competing priorities in a fast-paced work environment
• Candidates must be able to work in the US for any employer at this time
Other Beneficial Skill Sets
• Experience within an industrial product development environment
• Experience in working with chemicals and biochemical buffers and molecules
• Experience in process optimization using e.g. DOE and/or data acquisition and analysis systems
• Experience in building and operating automated and robotic systems
• Experience in industrial process verification and validation
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Santa Clara, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
She/He/They will work closely with other Fluxus teams and will perform instrument development tasks related to novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. Activities will involve amongst others the testing, development and optimization of functional biochips, fluidic cartridges, and analytical instruments. The successful applicant will work within a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.
Principal Duties and Responsibilities
• Support diverse aspects related to the product development of biochip-based, optofluidic diagnostics platforms. Applies diversified knowledge of interdisciplinary knowledge to understand, test and optimize all aspects of the technology
• Development, optimization & testing of biochips, cartridges and instruments, in collaboration with other groups and external suppliers
• Provide support in preparing documentation
• Use Good Documentation Practices (GDP) while authoring Experimental summaries, DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations
• Process development and optimization related to biomolecular sensing
• Support all aspects of technology transfer to and from development partners
• Develop, test and execute QC procedures
• Process troubleshooting to determine root cause and find possible engineering solutions
Requirements
• M.S. Degree in bio-, mechanical-, electrical- or chemical engineering, chemistry or biochemistry, or related, technical discipline, with 2+ years hands-on R&D or engineering or product development experience
• Inquisitive, interdisciplinary mindset
• Extensive, hands-on experience working with and optimizing complex instrumentation
• Excellent organizational as well as English (verbal and written) communication skills
• Experienced in using diverse instruments such as – or similar to e.g. – analytical instrumentation, DAQ interfaces, UV-VIS spectrometer, scanning electron microscope (SEM)
• Good knowledge of data analysis methods including good knowledge of statistics
• Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic
• Ability and willingness to quickly learn and apply new skills, procedures and approaches
• Proven ability to work collaboratively in a team-based environment
• Proven ability to handle multiple competing priorities in a fast-paced work environment
• Candidates must be able to work in the US for any employer at this time
Other Beneficial Skill Sets
• Experience within an industrial product development environment
• Experience in working with chemicals and biochemical buffers and molecules
• Experience in process optimization using e.g. DOE and/or data acquisition and analysis systems
• Experience in building and operating automated and robotic systems
• Experience in industrial process verification and validation
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Santa Clara, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
via SquarePeg Hires
posted_at: 5 days agoschedule_type: Full-time
To support its life science tool and diagnostics product development, Fluxus Inc. is seeking a highly motivated, interdisciplinary software engineer with relevant, hands-on experience and proven track record of innovative engineering at the intersection of software and hardware development. She/He will be part of Fluxus’ product development team and work closely with other teams to design... develop, and implement a rowing suite of bioanalytical
To support its life science tool and diagnostics product development, Fluxus Inc. is seeking a highly motivated, interdisciplinary software engineer with relevant, hands-on experience and proven track record of innovative engineering at the intersection of software and hardware development. She/He will be part of Fluxus’ product development team and work closely with other teams to design... develop, and implement a rowing suite of bioanalytical solutions comprised of integrated biochips, proprietary reagents, and custom instrumentation. The position will involve a variety of activities related to the design, control, and interfacing of various electronic and data analysis systems. Development of single-molecule detection technology will involve optoelectronic signal integration and programmatic/hardware data analysis. The successful applicant will work within multidisciplinary teams of engineers, scientists, and manufacturing specialists.
Responsibilities
• Lead/Support diverse aspects of software and UI development related to the development of novel, diagnostic instrument platforms
• Develop control/analysis software for RUO (Research Use Only) and FDA regulated instrumentation
• Contribute to a custom user interface for scientific and medical diagnostic systems
• Work with external software/hardware engineers towards fulfilment of Fluxus’ software goals (collaborate, peer review, architect and oversee execution)
• Support all aspects of technology transfer to and from internal and external partners.
Requirements
• Degree/Experience Requirements: B.S./M.S. with 3+ years of relevant experience
• Significant experience with instrument related software engineering using C# (or adjacent language)
• Significant experience with industry coding best practices (Git management, unit testing, documentation, etc.)
• Experience developing and supporting user interfaces
• Experience developing, implementing, consuming, and supporting contracted APIs
• Technical capabilities allowing interfacing with all vertical levels of contributors (i.e., engineer to CTO)
• Preferred Skill Sets
• Experience with firmware level interaction
• Experience with delivering quality conformant software (SaMD)
• Experience with Python programming
• Worked with frontend frameworks (React)
• Ability to develop custom equipment with external vendors and/or internal engineering resources
• Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic Show more details...
Responsibilities
• Lead/Support diverse aspects of software and UI development related to the development of novel, diagnostic instrument platforms
• Develop control/analysis software for RUO (Research Use Only) and FDA regulated instrumentation
• Contribute to a custom user interface for scientific and medical diagnostic systems
• Work with external software/hardware engineers towards fulfilment of Fluxus’ software goals (collaborate, peer review, architect and oversee execution)
• Support all aspects of technology transfer to and from internal and external partners.
Requirements
• Degree/Experience Requirements: B.S./M.S. with 3+ years of relevant experience
• Significant experience with instrument related software engineering using C# (or adjacent language)
• Significant experience with industry coding best practices (Git management, unit testing, documentation, etc.)
• Experience developing and supporting user interfaces
• Experience developing, implementing, consuming, and supporting contracted APIs
• Technical capabilities allowing interfacing with all vertical levels of contributors (i.e., engineer to CTO)
• Preferred Skill Sets
• Experience with firmware level interaction
• Experience with delivering quality conformant software (SaMD)
• Experience with Python programming
• Worked with frontend frameworks (React)
• Ability to develop custom equipment with external vendors and/or internal engineering resources
• Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic Show more details...
via SquarePeg
posted_at: 5 days agoschedule_type: Full-time
Fluxus Inc. is seeking a highly motivated and experienced individual to lead the manufacturing group, manufacturing process development/engineering as well as quality insurance related to the development and commercialization of a novel diagnostics platform.
She/He will work to maintain and provide continuous optimization in the manufacture of diagnostic cartridges involving biochips and plastic... consumables, including process development and supply
Fluxus Inc. is seeking a highly motivated and experienced individual to lead the manufacturing group, manufacturing process development/engineering as well as quality insurance related to the development and commercialization of a novel diagnostics platform.
She/He will work to maintain and provide continuous optimization in the manufacture of diagnostic cartridges involving biochips and plastic... consumables, including process development and supply chain management.
Together with Fluxus R&D teams, the candidate will also be involved in process transfer from R&D and manufacturing process optimization. The successful applicant will work within a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a clean environment setting and/or in a BSL2 laboratory area involving handling of human patient fluid samples.
Fluxus, Inc. is an innovator in single-molecule detection and ultra-high sensitivity platforms based on its expertise in optofluidics, assay development, system integration and microsystem technologies. The Fluxus product development infrastructure and suite of proprietary technologies are ideally suited for the robust development of advanced diagnostic products.
Responsibilities
• Manage the Fluxus Manufacturing, Manufacturing Engineering and Quality teams
• Ensure supply meets demand and quality related to diagnostic consumables and systems
• Lead process development and engineering towards a stable and reliable manufacturing operation. Applies intensive and diversified knowledge of process optimization, engineering, design and optimization principles, and practices related to complex systems
• Responsible for supply chain management
• Develop, test and validate quality control tools, processes and procedures
• Provide support in the maintenance and optimization of the eQMS system
• Development, optimization, testing, sourcing and scale-up of biochips, cartridges and instruments, in collaboration with other groups and external suppliers
• Support in preparing documentation and managing external suppliers and engineering partners for regulatory submissions
• Use and develop Good Documentation Practices (GDP) while authoring DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations
• Support all aspects of manufacturing technology transfer to and from development partners
• Interface with internal resources and external vendors to design, test and validate equipment
• Working knowledge of cGMPs, quality requirements for various regulatory agencies like FDA Certification is preferred
• Requirements
• BS or MS Degree in and engineering or related, technical discipline
• 7+ years of hands-on R&D and/or engineering and/or process/product development experience preferably in a biotechnology-related, industrial, product development/manufacturing environment.
• Interdisciplinary mindset
• Hands on experience with optimizing processes involving materials, micro-fluidics, reagents and electronics. Knowledge of DOE process optimization preferred.
• Hands-on experience in the development of processes related to e.g., precision plastic consumables, microfabrication and systems involving reagents and liquids.
• Good knowledge of data analysis methods / statistics.
• Ability to develop custom equipment by collaborating with external vendors or internal engineering resources.
• Experienced in cGMPs and operating under a QMS
• Experienced in verification and validation of instruments and processes.
• Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic.
• Excellent organizational as well as English verbal and written communication skills.
• Ability and willingness to quickly learn and apply new skills, procedures, and approaches.
• Proven ability to work collaboratively in a team-based environment.
• Proven ability to handle multiple competing priorities in a fast-paced work environment.
• Other Beneficial Skill Sets
• Experience in CAD design
• Knowledge of medical device and quality system regulations and standards (i.e., FDA QSR,ISO13485)
• Experience in industrial process verification and validation Show more details...
She/He will work to maintain and provide continuous optimization in the manufacture of diagnostic cartridges involving biochips and plastic... consumables, including process development and supply chain management.
Together with Fluxus R&D teams, the candidate will also be involved in process transfer from R&D and manufacturing process optimization. The successful applicant will work within a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a clean environment setting and/or in a BSL2 laboratory area involving handling of human patient fluid samples.
Fluxus, Inc. is an innovator in single-molecule detection and ultra-high sensitivity platforms based on its expertise in optofluidics, assay development, system integration and microsystem technologies. The Fluxus product development infrastructure and suite of proprietary technologies are ideally suited for the robust development of advanced diagnostic products.
Responsibilities
• Manage the Fluxus Manufacturing, Manufacturing Engineering and Quality teams
• Ensure supply meets demand and quality related to diagnostic consumables and systems
• Lead process development and engineering towards a stable and reliable manufacturing operation. Applies intensive and diversified knowledge of process optimization, engineering, design and optimization principles, and practices related to complex systems
• Responsible for supply chain management
• Develop, test and validate quality control tools, processes and procedures
• Provide support in the maintenance and optimization of the eQMS system
• Development, optimization, testing, sourcing and scale-up of biochips, cartridges and instruments, in collaboration with other groups and external suppliers
• Support in preparing documentation and managing external suppliers and engineering partners for regulatory submissions
• Use and develop Good Documentation Practices (GDP) while authoring DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations
• Support all aspects of manufacturing technology transfer to and from development partners
• Interface with internal resources and external vendors to design, test and validate equipment
• Working knowledge of cGMPs, quality requirements for various regulatory agencies like FDA Certification is preferred
• Requirements
• BS or MS Degree in and engineering or related, technical discipline
• 7+ years of hands-on R&D and/or engineering and/or process/product development experience preferably in a biotechnology-related, industrial, product development/manufacturing environment.
• Interdisciplinary mindset
• Hands on experience with optimizing processes involving materials, micro-fluidics, reagents and electronics. Knowledge of DOE process optimization preferred.
• Hands-on experience in the development of processes related to e.g., precision plastic consumables, microfabrication and systems involving reagents and liquids.
• Good knowledge of data analysis methods / statistics.
• Ability to develop custom equipment by collaborating with external vendors or internal engineering resources.
• Experienced in cGMPs and operating under a QMS
• Experienced in verification and validation of instruments and processes.
• Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic.
• Excellent organizational as well as English verbal and written communication skills.
• Ability and willingness to quickly learn and apply new skills, procedures, and approaches.
• Proven ability to work collaboratively in a team-based environment.
• Proven ability to handle multiple competing priorities in a fast-paced work environment.
• Other Beneficial Skill Sets
• Experience in CAD design
• Knowledge of medical device and quality system regulations and standards (i.e., FDA QSR,ISO13485)
• Experience in industrial process verification and validation Show more details...
via Lever
schedule_type: Full-time
To support its life science tool and diagnostics productdevelopment, Fluxus Inc. is seeking a highly motivated, interdisciplinary Senior Software Engineer with relevant, hands-on experience and proven track record of innovative engineering at the intersection of software and hardware development. She/He will be part of Fluxus’ product development team and work closely with other teams to design... develop, and implement a growing suite of bioanalytical
To support its life science tool and diagnostics productdevelopment, Fluxus Inc. is seeking a highly motivated, interdisciplinary Senior Software Engineer with relevant, hands-on experience and proven track record of innovative engineering at the intersection of software and hardware development. She/He will be part of Fluxus’ product development team and work closely with other teams to design... develop, and implement a growing suite of bioanalytical solutions comprised of integrated biochips, proprietary reagents, and custom instrumentation. The position will involve a variety of activities related to the design, control, and interfacing of various electronic and data analysis systems. Development of single-molecule detection technology will involve optoelectronic signal integration and programmatic/hardware data analysis. The successful applicant will work within multidisciplinary teams of engineers, scientists, and manufacturing specialists.
Principal duties and responsibilities
· Lead/Support diverse aspects of software and UI development related to the development of novel, diagnostic instrument platforms
· Develop control/analysis software for RUO (Research Use Only) and FDA regulated instrumentation
· Contribute to a custom user interface for scientific and medical diagnostic systems
· Work with external software/hardware engineers towards fulfilment of Fluxus’ software goals (collaborate, peer review, architect and oversee execution)
· Support all aspects of technology transfer to and from internal and external partners
Requirements
· Degree/Experience Requirements
· B.S./M.S. with 7+ years of relevant experience
· Significant experience with instrument-related software engineering using C# (or adjacent language)
· Significant experience with industry coding best practices (Git management, unit testing, documentation, etc.)
· Experience developing, implementing, consuming, and supporting contracted APIs
· Technical capabilities allowing interfacing with all vertical levels of contributors (i.e. engineer to CTO)
Preferred skillsets
· Experience with firmware level interaction
· Experience with delivering quality conformant software (SaMD)
· Experience with interface standards (GraphQL, OpenAPI)
· Experience with Python programming
· Experience with complex data analysis challenges
· Worked with frontend frameworks (React)
· Ability to develop custom equipment with external vendors and/or internal engineering resources
· Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Santa Clara, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
Principal duties and responsibilities
· Lead/Support diverse aspects of software and UI development related to the development of novel, diagnostic instrument platforms
· Develop control/analysis software for RUO (Research Use Only) and FDA regulated instrumentation
· Contribute to a custom user interface for scientific and medical diagnostic systems
· Work with external software/hardware engineers towards fulfilment of Fluxus’ software goals (collaborate, peer review, architect and oversee execution)
· Support all aspects of technology transfer to and from internal and external partners
Requirements
· Degree/Experience Requirements
· B.S./M.S. with 7+ years of relevant experience
· Significant experience with instrument-related software engineering using C# (or adjacent language)
· Significant experience with industry coding best practices (Git management, unit testing, documentation, etc.)
· Experience developing, implementing, consuming, and supporting contracted APIs
· Technical capabilities allowing interfacing with all vertical levels of contributors (i.e. engineer to CTO)
Preferred skillsets
· Experience with firmware level interaction
· Experience with delivering quality conformant software (SaMD)
· Experience with interface standards (GraphQL, OpenAPI)
· Experience with Python programming
· Experience with complex data analysis challenges
· Worked with frontend frameworks (React)
· Ability to develop custom equipment with external vendors and/or internal engineering resources
· Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Santa Clara, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
via Lever
schedule_type: Full-time
To support its product development activities, Fluxus Inc. is seeking a highly motivated Manufacturing Associate / Technician with relevant, hands-on experience in diverse process development tasks as well as in the assembly, manufacturing and instrument operation related to the biomedical field. She/He/They will be part of an interdisciplinary product development team and will play an important... role in the execution and implementation of manufacturing
To support its product development activities, Fluxus Inc. is seeking a highly motivated Manufacturing Associate / Technician with relevant, hands-on experience in diverse process development tasks as well as in the assembly, manufacturing and instrument operation related to the biomedical field. She/He/They will be part of an interdisciplinary product development team and will play an important... role in the execution and implementation of manufacturing processes, as well as in the execution of testing and QC tasks related to a novel diagnostics platform.
The Manufacturing Associate / Technician will work in support of manufacturing growth and improvement initiatives. She/He/They will be responsible for the assembly and release testing of test cartridges to support product development activities. They will also assist in the development and implementation of new processes, product transfer to manufacturing, process enhancements, and design and qualification of process equipment. They will develop, sustain, improve production capabilities for manufacturing.
Principal Duties and Responsibilities
• Support pilot production, assembly, and QC testing of products
• Align, fit, or assemble component parts, using hand or power tools, fixtures, templates, or microscopes
• Assist in performing studies, experiments, first article inspections, and tool/fixture qualifications as needed
• Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality, and safety performance
• Verify part dimensions or perform testing to ensure conformance to specifications, using precision measuring instruments
• Assist in the design and development of manufacturing processes for product changes and enhancements
• Assist in the design, development, documentation, and implementation of manufacturing-related tools and fixtures
• Complete accurate and timely manufacturing documentation including manufacturing procedures, batch records, quality records, etc
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
Requirements
• Requires a high school diploma or equivalent or higher
• 3-5 years of experience in the medical device industry or similar
• Good manual dexterity and fine motor skills. Experience in the assembly of high-precision parts under a binocular or using other magnification tools
• Experience in using and applying diverse types of assembly equipment, such as mechanical assembly jigs, UV-gluing; bonding and plasma cleaning
• Ability and willingness to quickly learn and apply new skills, procedures and approaches
• Attention to detail; able to follow detailed written and oral instructions
• Good English verbal and written communication skills. Capable of writing detailed observations
• Knowledge in following Good Documentation Practices (GDP) while executing Manufacturing process instructions (MPIs), SOPs, Batch records (BRs) and Forms (FRs) for various unit operations
• Hands-on experience in making assemblies involving miniature parts, materials, plastics, reagents and electronics components
• Interest and eagerness to learn and help optimize novel processes in an interdisciplinary environment
• Detail-oriented, motivated, thoughtful, and with a strong work ethic
• Proven ability to work collaboratively in a team-based environment
• Experience and knowledge of working in the medical device industry in GMP/FDA regulated environment
• Candidates must be able to work in the US for any employer at this time
Other Beneficial Skill Sets
• Hands on experience in the assembly of medical devices and consumables, including reagents.
• Hands-on experience in wet-chemical processing, such as e.g. cleanroom processes, plastic processing and/or chemical surface modifications
• Hands-on experience in using (prototype)-manufacturing equipment, such as e.g. laser cutters, 3D printers, and mills
• Experience working with microchips or microfluidics
• Experience with 3D CAD software (e.g. Autocad Inventor or Solidworks)
• Proficient in Word, Excel, PowerPoint, Outlook, JMP
• Experience in operating automated and robotic systems
• Experience in process verification and validation.
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Santa Clara, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
The Manufacturing Associate / Technician will work in support of manufacturing growth and improvement initiatives. She/He/They will be responsible for the assembly and release testing of test cartridges to support product development activities. They will also assist in the development and implementation of new processes, product transfer to manufacturing, process enhancements, and design and qualification of process equipment. They will develop, sustain, improve production capabilities for manufacturing.
Principal Duties and Responsibilities
• Support pilot production, assembly, and QC testing of products
• Align, fit, or assemble component parts, using hand or power tools, fixtures, templates, or microscopes
• Assist in performing studies, experiments, first article inspections, and tool/fixture qualifications as needed
• Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality, and safety performance
• Verify part dimensions or perform testing to ensure conformance to specifications, using precision measuring instruments
• Assist in the design and development of manufacturing processes for product changes and enhancements
• Assist in the design, development, documentation, and implementation of manufacturing-related tools and fixtures
• Complete accurate and timely manufacturing documentation including manufacturing procedures, batch records, quality records, etc
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
Requirements
• Requires a high school diploma or equivalent or higher
• 3-5 years of experience in the medical device industry or similar
• Good manual dexterity and fine motor skills. Experience in the assembly of high-precision parts under a binocular or using other magnification tools
• Experience in using and applying diverse types of assembly equipment, such as mechanical assembly jigs, UV-gluing; bonding and plasma cleaning
• Ability and willingness to quickly learn and apply new skills, procedures and approaches
• Attention to detail; able to follow detailed written and oral instructions
• Good English verbal and written communication skills. Capable of writing detailed observations
• Knowledge in following Good Documentation Practices (GDP) while executing Manufacturing process instructions (MPIs), SOPs, Batch records (BRs) and Forms (FRs) for various unit operations
• Hands-on experience in making assemblies involving miniature parts, materials, plastics, reagents and electronics components
• Interest and eagerness to learn and help optimize novel processes in an interdisciplinary environment
• Detail-oriented, motivated, thoughtful, and with a strong work ethic
• Proven ability to work collaboratively in a team-based environment
• Experience and knowledge of working in the medical device industry in GMP/FDA regulated environment
• Candidates must be able to work in the US for any employer at this time
Other Beneficial Skill Sets
• Hands on experience in the assembly of medical devices and consumables, including reagents.
• Hands-on experience in wet-chemical processing, such as e.g. cleanroom processes, plastic processing and/or chemical surface modifications
• Hands-on experience in using (prototype)-manufacturing equipment, such as e.g. laser cutters, 3D printers, and mills
• Experience working with microchips or microfluidics
• Experience with 3D CAD software (e.g. Autocad Inventor or Solidworks)
• Proficient in Word, Excel, PowerPoint, Outlook, JMP
• Experience in operating automated and robotic systems
• Experience in process verification and validation.
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Santa Clara, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
via Lever
schedule_type: Full-time
To support its optofluidic platform technology development, Fluxus Inc. is seeking a highly motivated, interdisciplinary product development engineer with relevant, hands-on experience. She/He/They will be part of the product development team and will play a vital role in product prototyping as well as in the design, testing and the implementation of manufacturing equipment.
The applicant will... work closely with the other Fluxus teams and will
To support its optofluidic platform technology development, Fluxus Inc. is seeking a highly motivated, interdisciplinary product development engineer with relevant, hands-on experience. She/He/They will be part of the product development team and will play a vital role in product prototyping as well as in the design, testing and the implementation of manufacturing equipment.
The applicant will... work closely with the other Fluxus teams and will integrate assays/reagents, consumables, instruments, and software. Activities will involve amongst others the development, optimization and manufacturing of functional biochips, fluidic cartridges and analytical instruments. The successful applicant will work within a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a cleanroom setting.
Principal Duties and Responsibilities
• Lead interdisciplinary engineering activities and projects at Fluxus Inc. and with external development partners
• Support diverse aspects related to the product development of a bio-chip based, optofluidic diagnostics platform. Applies intensive and diversified knowledge of design principles, practices and implementation in complex systems and assignments
• Development, optimization, testing, sourcing and scale-up of biochips, cartridges and instruments, in collaboration with other groups, external suppliers and CMOs
• Provide continuous development support to international collaborators
• Managing and providing support in preparing documentation of/for external suppliers and engineering partners as well as for regulatory submissions
• Use Good Documentation Practices (GDP) while authoring DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations
• Process development and optimization related to biomolecular sensing
• Support all aspects of technology transfer to and from development partners
• Interface with internal resources and external vendors to design, test and validate equipment
• Develop, test and execute QC procedures
• Working knowledge of cGMP, quality requirements for various regulatory agencies like FDA
• Certification is preferred
• Process troubleshooting to determine root cause and possible engineering solutions
Requirements
• M.S. Degree in mechanical-, electrical-, bio- or chemical engineering, chemistry or biochemistry, or related, technical discipline, with 5-10 years hands-on engineering or product development experience
• Experience in project management and people management
• Experience in developing custom equipment by collaborating with external vendors or internal engineering resources
• Extensive, hands-on experience in mechanical design and an in building and operating electronic systems
• Proficiency in CAD design and managing CAD portfolios
• Interdisciplinary mindset
• Experience with statistical analysis software as well as with instrument-oriented programming language(s) (e.g. Python; LabView)
• Excellent organizational as well as English verbal and written communication skills
• Hands-on experience with standard biotech laboratory and/or manufacturing equipment and working with biological or biochemical systems (e.g. proteins, nucleic-acids, cells and/or bio-organic molecules)
• Experienced in using diverse, analytical instruments such as – or similar to – e.g. oscilloscopes, DAQ interfaces
• Proven ability to handle multiple competing priorities in a fast-paced work environment
• Experienced in cGMPs and in authoring DOPs, BRs, FRs
• Experienced in verification and validation of instruments and processes
• Good knowledge of data analysis methods including good knowledge of statistics
• Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic
• Ability and willingness to quickly learn and apply new skills, procedures and approaches
• Proven ability to work collaboratively in a team-based environment
• Candidates must be able to work in the US for any employer at this time
Other Beneficial Skill Sets
• Experience within an industrial product development environment
• Working knowledge of medical device and quality system regulations and standards (i.e. FDA QSR, ISO13485)
• Experience in building and operating automated and robotic systems
• Experience in industrial process verification and validation
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Santa Clara, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
The applicant will... work closely with the other Fluxus teams and will integrate assays/reagents, consumables, instruments, and software. Activities will involve amongst others the development, optimization and manufacturing of functional biochips, fluidic cartridges and analytical instruments. The successful applicant will work within a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a cleanroom setting.
Principal Duties and Responsibilities
• Lead interdisciplinary engineering activities and projects at Fluxus Inc. and with external development partners
• Support diverse aspects related to the product development of a bio-chip based, optofluidic diagnostics platform. Applies intensive and diversified knowledge of design principles, practices and implementation in complex systems and assignments
• Development, optimization, testing, sourcing and scale-up of biochips, cartridges and instruments, in collaboration with other groups, external suppliers and CMOs
• Provide continuous development support to international collaborators
• Managing and providing support in preparing documentation of/for external suppliers and engineering partners as well as for regulatory submissions
• Use Good Documentation Practices (GDP) while authoring DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations
• Process development and optimization related to biomolecular sensing
• Support all aspects of technology transfer to and from development partners
• Interface with internal resources and external vendors to design, test and validate equipment
• Develop, test and execute QC procedures
• Working knowledge of cGMP, quality requirements for various regulatory agencies like FDA
• Certification is preferred
• Process troubleshooting to determine root cause and possible engineering solutions
Requirements
• M.S. Degree in mechanical-, electrical-, bio- or chemical engineering, chemistry or biochemistry, or related, technical discipline, with 5-10 years hands-on engineering or product development experience
• Experience in project management and people management
• Experience in developing custom equipment by collaborating with external vendors or internal engineering resources
• Extensive, hands-on experience in mechanical design and an in building and operating electronic systems
• Proficiency in CAD design and managing CAD portfolios
• Interdisciplinary mindset
• Experience with statistical analysis software as well as with instrument-oriented programming language(s) (e.g. Python; LabView)
• Excellent organizational as well as English verbal and written communication skills
• Hands-on experience with standard biotech laboratory and/or manufacturing equipment and working with biological or biochemical systems (e.g. proteins, nucleic-acids, cells and/or bio-organic molecules)
• Experienced in using diverse, analytical instruments such as – or similar to – e.g. oscilloscopes, DAQ interfaces
• Proven ability to handle multiple competing priorities in a fast-paced work environment
• Experienced in cGMPs and in authoring DOPs, BRs, FRs
• Experienced in verification and validation of instruments and processes
• Good knowledge of data analysis methods including good knowledge of statistics
• Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic
• Ability and willingness to quickly learn and apply new skills, procedures and approaches
• Proven ability to work collaboratively in a team-based environment
• Candidates must be able to work in the US for any employer at this time
Other Beneficial Skill Sets
• Experience within an industrial product development environment
• Working knowledge of medical device and quality system regulations and standards (i.e. FDA QSR, ISO13485)
• Experience in building and operating automated and robotic systems
• Experience in industrial process verification and validation
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Santa Clara, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
via Bevov - BioPharma Jobs
posted_at: 21 days agoschedule_type: Full-time
To support its optofluidic platform technology development, Fluxus Inc. is seeking a highly motivated, interdisciplinary research scientist with relevant, hands-on experience and proven track record of innovative science at the intersection of photonics, materials science, and biological applications. She/He/They will be part of Fluxus innovative research team and work closely with other teams to... design, develop, and test a growing suite of optofluidic
To support its optofluidic platform technology development, Fluxus Inc. is seeking a highly motivated, interdisciplinary research scientist with relevant, hands-on experience and proven track record of innovative science at the intersection of photonics, materials science, and biological applications. She/He/They will be part of Fluxus innovative research team and work closely with other teams to... design, develop, and test a growing suite of optofluidic solutions comprised of integrated biochips, proprietary reagents, and custom instrumentation. Activities will involve a variety of biochemical assays at the single-molecule detection level. Development of single-molecule detection technology will involve novel reagents and fluidic cartridges, as well as instrumentation for detection, sample preparation and corresponding software. The successful applicant will work within a multidisciplinary team of engineers, scientists, and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human biological materials such as blood samples. Other activities might be conducted in a cleanroom setting.
Principal Duties and Responsibilities
Support diverse aspects related to the development of biochip based, optofluidic diagnostics platforms.
Design, optimization, testing, and validation of optofluidic chips, optical/fluidic interfaces, sample processing technology, and instruments, in collaboration with other groups and external suppliers.
Develop, evolve, and maintain custom optoelectronic systems used for testing and characterizing optofluidic systems.
Analyze and present data of various types including images, time traces, assay flows, optical spectrums, etc.
Requirements
MS/PhD in bio-, mechanical-, electrical- or chemical engineering, chemistry, physics, biochemistry, or related discipline, with 5+ years hands-on R&D or engineering experience.
Extensive theoretical and hands-on experience in optics/photonics
Experience simulating in Multiphysics environments (e.g. Comsol, Lumerical)
Capability to analyze and present complex, acquired data
Experienced in using diverse, analytical instruments such as or similar to oscilloscopes, DAQ interfaces, UV-VIS spectrometers, scanning electron microscopes (SEMs), fluorescence microscopes, etc.
Other Beneficial Skill Sets
Candidates with expertise in optofluidics are highly preferred.
Experience in designing, building, utilizing, and maintaining optical systems (free space and chip based) and in using simulation software: e.g., ray tracing software for system design and FEM/FDM/BPM/etc. for chip design.
Proficiency in statistical analysis (Python, JMP, MATLAB, etc.), along with instrument-oriented programming experience (Python; LabView).
Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic.
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Sunnyvale, CA, USA. The Companys immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
Principal Duties and Responsibilities
Support diverse aspects related to the development of biochip based, optofluidic diagnostics platforms.
Design, optimization, testing, and validation of optofluidic chips, optical/fluidic interfaces, sample processing technology, and instruments, in collaboration with other groups and external suppliers.
Develop, evolve, and maintain custom optoelectronic systems used for testing and characterizing optofluidic systems.
Analyze and present data of various types including images, time traces, assay flows, optical spectrums, etc.
Requirements
MS/PhD in bio-, mechanical-, electrical- or chemical engineering, chemistry, physics, biochemistry, or related discipline, with 5+ years hands-on R&D or engineering experience.
Extensive theoretical and hands-on experience in optics/photonics
Experience simulating in Multiphysics environments (e.g. Comsol, Lumerical)
Capability to analyze and present complex, acquired data
Experienced in using diverse, analytical instruments such as or similar to oscilloscopes, DAQ interfaces, UV-VIS spectrometers, scanning electron microscopes (SEMs), fluorescence microscopes, etc.
Other Beneficial Skill Sets
Candidates with expertise in optofluidics are highly preferred.
Experience in designing, building, utilizing, and maintaining optical systems (free space and chip based) and in using simulation software: e.g., ray tracing software for system design and FEM/FDM/BPM/etc. for chip design.
Proficiency in statistical analysis (Python, JMP, MATLAB, etc.), along with instrument-oriented programming experience (Python; LabView).
Self-starter, detail-oriented, motivated, thoughtful, and with a strong work ethic.
About Fluxus
Fluxus Inc. is a privately held development-stage medical device company located in Sunnyvale, CA, USA. The Companys immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.
As a member of Fluxus team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law Show more details...
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