Senior Lead Systems Engineer, MedTech & V&V Expert

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

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.