Chief Systems Engineer, Benchtop Blood Gas

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.

• 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.

• 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…