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Engineering Manager

Job in Newton, Middlesex County, Massachusetts, 02165, USA
Listing for: X4 Life Sciences
Full Time position
Listed on 2026-09-13
Job specializations:
  • Business
    Operations Management, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 200000 - 260000 USD Yearly USD 200000.00 260000.00 YEAR
Job Description & How to Apply Below

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.

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