X4 Life Sciences
Lead Systems Engineer
Skills
1 month ago
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Important information
Contract type:
Permanent
Location:
Massachusetts, USA
Work mode:
Onsite
Published on:
7 October 2026
What they need
Lead Systems Engineer
Already leading on the technical side and ready to take that further? This is an opportunity to expand an existing track record of technical leadership into a more senior, formal leadership role, with greater scope, more responsibility, and real support to grow into it.
You'll join a well-established medical device organization as a technical leader who stays close to the engineering, still hands-on, still solving problems alongside your team, while taking on broader responsibility for direction, mentorship, and decision-making across your area. You'll also be a regular voice in front of the executive team, representing your area's technical direction, progress, and risk posture at that level. This is a genuine next step for someone who has already been operating as a technical lead in some capacity and wants that responsibility formalized and expanded, with structured development to build out the leadership side further.
What you'll own:
- Systems engineering across the full product lifecycle
- Risk management - genuine ownership of hazard analysis, FMEAs, and the Risk Management File (ISO 14971), not just contribution to it
- Verification & Validation - test strategy, protocol development, and requirements traceability
- Direction, mentorship, and technical decision-making for engineers looking to you for leadership
- A support-related database management component within the broader engineering function
- Regular, direct communication with the executive team on technical and risk matters
- Continued growth into a more senior leadership remit, with real investment in developing that side of your career
What you bring:
- Senior-level systems engineering experience in medical device or IVD/diagnostics — this is essential
- Demonstrated ownership of risk management documentation and decisions, not just familiarity with the process
- Strong, hands-on V&V experience
- Some form of existing technical leadership - whether that's a formal technical lead title, leading initiatives, or being the person others turn to for direction — is required; this is about expanding that, not starting from scratch
- A genuine desire to grow further into a more senior leadership position, with the ambition and self-awareness to develop the people-leadership skills that come with it
- Excellent communication skills are required - you'll need to move comfortably between hands-on engineering conversations and clear, confident updates to senior executives.
This is an opportunity for someone who's already proven themselves as a technical leader to take the next real step, with genuine mentorship and room to grow rather than being left to figure it out alone.
Please apply here, or reach out directly to [email protected]
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