Engineering Manager

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 #J-18808-Ljbffr