Senior Manager Systems Engineering

Senior Manager Systems EngineeringMedical Device Industry | Class II / III DevicesLeadership + 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 programmesDriving hands-on development of verification plans, protocols, and traceable test cases linked to requirements and risk analysisOwning risk identification, mitigation, and closure across complex systemsLeading system integration activities across software, hardware, mechanical, and analytical teamsPartnering 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 closureSupporting technical decision-making across concept, feasibility, and development phasesMentoring 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 60601Strong understanding of both hardware and software systems integrationDegree 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+ engineersExperience within Class II or Class III medical devicesExperience with Human Factors and Usability Engineering preferred
Ideal industry experience includes IVD, Life Sciences, Medical Imaging, or broader MedTech
If interested, please apply and reach out to [email protected]