Medical Device Engineering
Project Manager, Medical Device
Lead regulated medical device product development programs involving robotics, electromechanical systems, embedded software, cloud, and quality controls.
Role overview
Role overview
Lead complex new product development and sustaining engineering programs in regulated medical device environments.
Responsibilities
- Manage schedule, budget, risks, issues, RAID logs, resources, and executive reporting.
- Lead cross-functional engineering, quality, regulatory, manufacturing, commercial, and software teams.
- Oversee robotics, electromechanical systems, embedded software, cloud applications, connected systems, and lifecycle delivery.
- Apply Agile and DevOps practices where appropriate.
- Ensure compliance with design controls, QMS expectations, DHF artifacts, and phase review processes.
Requirements
- Engineering or related degree.
- Significant program or project management experience in medical device or regulated product development.
- PMP, PRINCE2, Agile PM, MS Office, project management tools, design controls, FDA-regulated development, and strong executive communication experience.
Skills and signals
Medical devicesProject managementDesign controlsFDA-regulated developmentRoboticsEmbedded softwareCloud applicationsRAID logs
