Lead complex NPD programs (robotics, electromechanical systems, embedded software, cloud applications)
Manage project execution: schedule, budget, risks, and issues
Lead cross-functional teams across engineering, quality, regulatory, manufacturing, and commercial
Apply Agile & DevOps practices
Oversee cloud-based/connected solutions in regulated environments
Ensure compliance with design controls and QMS
Support DHF and phase review processes
Provide executive-level reporting
Drive product lifecycle from concept to launch (orthopaedics focus)
Manage sustaining engineering, enhancements, and cost reduction
Maintain RAID logs
Coordinate teams and resource allocation
Key Requirements
Education: Bachelors/Masters in Biomedical, Mechanical, or related field
Experience: 10+ years (5+ years in medical device project leadership)
Certifications: PMP / PRINCE2 / Agile PM
Technical Skills: MS Office, project management tools, CAD documentation
Domain Knowledge: Medical device design controls (21 CFR 820.