Siemens Healthineers · 1 day ago
Chief Systems Engineer, Benchtop Blood Gas
Walpole, MA
Full-time
Onsite
Director/Executive
$173K/yr - $237K/yr
15+ years expSiemens Healthineers is a leader in medical technology, pioneering breakthroughs in healthcare. The Chief Systems Engineer for the Benchtop Blood Gas platform will lead new product development initiatives, focusing on integration, verification, and troubleshooting of a complex diagnostic device for critical care environments.
Health CareHealth DiagnosticsMedicalMedical Device
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
Qualification
Required
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
Benefits
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
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Sebastian Kronmueller
Vice President, Head of Strategy & Business Development - Laboratory Diagnostics
Recent News
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2026-01-07
2026-01-07
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