Engineering Manager

X4 Life Sciences; Massachusetts; On-site; USD 120,000 - 160,000; Full time

Job summary

X4 Life Sciences is seeking a Senior Group Lead Systems Engineer to join the engineering leadership team in Massachusetts. This role involves leading the systems engineering strategy across complex medical device programs and guiding cross-functional teams. The ideal candidate will have extensive experience in systems engineering within regulated environments, particularly in Verification & Validation and Risk Management. Strong leadership skills and hands-on execution are essential for this position.

Qualifications

• 7–10+ years of experience in Systems Engineering.
• Experience managing teams of 5+ engineers.
• Experience within Class II or Class III medical devices.

Responsibilities

• Lead system-level V&V and risk management strategy.
• Drive development of verification plans and test cases.
• Own risk identification, mitigation, and closure.
• Lead integration activities across software and hardware teams.
• Ensure compliance and audit readiness with regulatory teams.

Skills

Hands-on experience in V&V

Risk management

Regulatory understanding

Systems integration

Leadership skills

Education

Degree in Electrical Engineering, Systems Engineering, Biomedical Engineering or related discipline

Job description

Medical Device Industry | Class II / III Devices

Leadership + Hands-On Technical Ownership

X4 Life Sciences are partnered with a leading medical device organisation seeking a Senior Group Lead Systems Engineer to join their engineering leadership team.

You’ll lead the systems engineering strategy across complex medical device programs, guiding cross‑functional teams through integration challenges, V&V execution, and risk‑based development activities from concept through submission readiness.

This is a role for a strong technical leader who remains hands‑on in execution, not just overseeing delivery.

We are looking for someone with deep experience in systems engineering within regulated environments, with particular strength in Verification & Validation and Risk Management.

Key responsibilities include:

• Leading system‑level V&V and risk management strategy across development programmes
• Driving hands‑on development of verification plans, protocols, and traceable test cases linked to requirements and risk analysis
• Owning risk identification, mitigation, and closure across complex systems
• Leading system integration activities across software, hardware, mechanical, and analytical teams
• Partnering with Quality and Regulatory teams to ensure compliance, audit readiness, and support for the Design History File (DHF)
• Leading defect review meetings and driving technical issues through to closure
• Supporting technical decision‑making across concept, feasibility, and development phases
• Mentoring and developing a team of systems engineers

Requirements:

• Hands‑on experience in V&V and risk management (not purely governance or oversight)
• Strong understanding of regulatory frameworks including FDA Design Controls, ISO 13485, ISO 14971, and IEC 60601
• Strong understanding of both hardware and software systems integration
• Degree in Electrical Engineering, Systems Engineering, Biomedical Engineering or related discipline (Master’s preferred)
• Strong Systems Engineering background (7–10+ years)
• Proven leadership experience managing teams of 5+ engineers
• Experience within Class II or Class III medical devices
• Experience with Human Factors and Usability Engineering preferred

Ideal industry experience includes IVD, Life Sciences, Medical Imaging, or broader MedTech