Manager, Sustaining Engineering
Core
Lead engineering for commercial medical device and combination product safety, reliability, and continuous improvement, managing design changes and risk management.
Role type
Manager, Sustaining Engineering
Builds
Commercial combination products and medical devices
Domain
Medical devices / Combination products / Life sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design change management, risk management, root cause analysis, corrective and preventive actions, design transfer, FDA regulations knowledge, Design History File management, manufacturing expertise, project leadership, technical writing
Preferred skills
Biomedical Engineering, Mechanical Engineering, Industrial Engineering
Technologies
21 CFR Part 3, 21 CFR 820.30
Responsibilities
Steer high-performing team, own design changes from concept to launch, drive risk management, file commercial products in new regions, support contract manufacturing changes, turn complaints into insight, partner with development team, lead and mentor engineers, implement targeted design changes, drive customer complaint investigations, facilitate design transfer, participate in cross-functional design teams, build stakeholder relationships
Seniority
Manager, people leadership
