Siemens Healthineers
Chief Systems Engineer, Benchtop Blood Gas
Siemens Healthineers, Walpole, Massachusetts, us, 02081
Chief Systems Engineer, Benchtop Blood Gas
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
As Chief Systems Engineer for the Benchtop Blood Gas platform, you will report to the Head of Systems Development and Integration and serve as the technical authority for new product development initiatives for bench top blood gas testing. This role blends deep systems engineering expertise with architectural governance and hands‑on troubleshooting. You will lead the integration, verification, and knowledge transfer of a complex, software‑driven diagnostic device designed for critical care environments.
Responsibilities
Function as the chief technical escalation point for system hardware and complex electromechanical interfaces, diving into the most intractable integration, testing, and performance challenges for current prototypes.
Provide critical technical leadership and expertise to support the V&V team, ensuring test protocols are robust, data is technically sound, and complex failures identified during testing are rapidly investigated and resolved.
Lead and execute advanced fault tree analyses (FTAs) and drive root cause investigations for complex system failures, translating findings into actionable design changes that maintain architectural integrity.
Review and approve major design change requests that impact critical system interfaces, performance, or regulatory compliance, acting as a technical steward to prevent architectural degradation in the face of in‑flight challenges.
Act as the primary technical conduit between internal R&D and external design/development partners, ensuring alignment on interface specifications, design constraints, and technical decision‑making.
Define and lead the technical strategy for robust, bidirectional knowledge transfer between internal teams and external partners. This includes creating detailed technical training materials, reviewing partner design outputs, and ensuring critical IP and design rationale are successfully internalized.
Own the meticulous definition, documentation, and rigorous management of all Interface Control Documents.
Provide expert technical input to system‑level FMEAs (Failure Modes and Effects Analysis) and contribute to the ISO 14971 risk management file, focusing on complex, cross‑subsystem risks.
Ensure continuous traceability between the high‑level system architecture, subsystem requirements, and verification test cases, particularly as design changes are implemented.
Serve as a key technical liaison with Assay Scientists, Software Engineering, and Hardware teams, facilitating trade‑offs and resolving conflicts at critical system integration points while maintaining system‑level coherence.
Lead the identification and integration of software requirements for IVD platforms, ensuring alignment with system dependencies and compliance with relevant medical device software standards (e.g., IEC 62304, ISO 13485, ISO 14971).
Ensure rigorous definition of platform‑level requirements and maintain end‑to‑end traceability through subsystem specifications and verification testing. Drive alignment between design intent, system architecture, and test coverage.
Required Knowledge/Skills, Education, and Experience
Minimum a Bachelor’s degree in a technical field (e.g., Electrical, Mechanical, Systems or Biomedical Engineering, Computer Science, or equivalent). Advanced degrees preferred.
Minimum 15+ years of progressive experience in an IVD or Medical Device product development environment, with a demonstrable track record in a lead technical role driving complex system integration and V&V.
Broad experience in systems design and development involving the integration of fluidics, optics, hardware, software, and consumables, specifically for high‑reliability Point‑of‑Care or Benchtop IVD platforms (blood gas experience highly preferred).
Proven expertise in structured problem‑solving methodologies and a strong ability to conduct hands‑on, deep‑dive technical investigations on complex prototypes.
Strong working knowledge of a development process consistent with FDA Design Control requirements, ISO 13485, and ISO 14971 Risk Management practices.
Demonstrated experience in successfully managing and ensuring technical alignment with external design or manufacturing partners.
We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision‑making and treatment pathways.
Salary and Benefits Min $172,680 - Max $259,020. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company’s plan. Commissions are based on individual performance and/or company performance.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long‑term and short‑term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.
Equal Employment Opportunity Statement Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
EEO is the law: Applicants and employees are protected under federal law from discrimination.
Reasonable accommodations are available for persons with disabilities. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.
California residents have the right to receive additional notices about their personal information. Export control compliance applies.
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Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
As Chief Systems Engineer for the Benchtop Blood Gas platform, you will report to the Head of Systems Development and Integration and serve as the technical authority for new product development initiatives for bench top blood gas testing. This role blends deep systems engineering expertise with architectural governance and hands‑on troubleshooting. You will lead the integration, verification, and knowledge transfer of a complex, software‑driven diagnostic device designed for critical care environments.
Responsibilities
Function as the chief technical escalation point for system hardware and complex electromechanical interfaces, diving into the most intractable integration, testing, and performance challenges for current prototypes.
Provide critical technical leadership and expertise to support the V&V team, ensuring test protocols are robust, data is technically sound, and complex failures identified during testing are rapidly investigated and resolved.
Lead and execute advanced fault tree analyses (FTAs) and drive root cause investigations for complex system failures, translating findings into actionable design changes that maintain architectural integrity.
Review and approve major design change requests that impact critical system interfaces, performance, or regulatory compliance, acting as a technical steward to prevent architectural degradation in the face of in‑flight challenges.
Act as the primary technical conduit between internal R&D and external design/development partners, ensuring alignment on interface specifications, design constraints, and technical decision‑making.
Define and lead the technical strategy for robust, bidirectional knowledge transfer between internal teams and external partners. This includes creating detailed technical training materials, reviewing partner design outputs, and ensuring critical IP and design rationale are successfully internalized.
Own the meticulous definition, documentation, and rigorous management of all Interface Control Documents.
Provide expert technical input to system‑level FMEAs (Failure Modes and Effects Analysis) and contribute to the ISO 14971 risk management file, focusing on complex, cross‑subsystem risks.
Ensure continuous traceability between the high‑level system architecture, subsystem requirements, and verification test cases, particularly as design changes are implemented.
Serve as a key technical liaison with Assay Scientists, Software Engineering, and Hardware teams, facilitating trade‑offs and resolving conflicts at critical system integration points while maintaining system‑level coherence.
Lead the identification and integration of software requirements for IVD platforms, ensuring alignment with system dependencies and compliance with relevant medical device software standards (e.g., IEC 62304, ISO 13485, ISO 14971).
Ensure rigorous definition of platform‑level requirements and maintain end‑to‑end traceability through subsystem specifications and verification testing. Drive alignment between design intent, system architecture, and test coverage.
Required Knowledge/Skills, Education, and Experience
Minimum a Bachelor’s degree in a technical field (e.g., Electrical, Mechanical, Systems or Biomedical Engineering, Computer Science, or equivalent). Advanced degrees preferred.
Minimum 15+ years of progressive experience in an IVD or Medical Device product development environment, with a demonstrable track record in a lead technical role driving complex system integration and V&V.
Broad experience in systems design and development involving the integration of fluidics, optics, hardware, software, and consumables, specifically for high‑reliability Point‑of‑Care or Benchtop IVD platforms (blood gas experience highly preferred).
Proven expertise in structured problem‑solving methodologies and a strong ability to conduct hands‑on, deep‑dive technical investigations on complex prototypes.
Strong working knowledge of a development process consistent with FDA Design Control requirements, ISO 13485, and ISO 14971 Risk Management practices.
Demonstrated experience in successfully managing and ensuring technical alignment with external design or manufacturing partners.
We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision‑making and treatment pathways.
Salary and Benefits Min $172,680 - Max $259,020. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company’s plan. Commissions are based on individual performance and/or company performance.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long‑term and short‑term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.
Equal Employment Opportunity Statement Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
EEO is the law: Applicants and employees are protected under federal law from discrimination.
Reasonable accommodations are available for persons with disabilities. If you require a reasonable accommodation in completing a job application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.
California residents have the right to receive additional notices about their personal information. Export control compliance applies.
#J-18808-Ljbffr