Senior Project Manager – Medical Devices

About the role

Lead structured sustainment programs for medical device portfolios, ensuring delivery within scope, schedule, and budget. Provide end‑to‑end governance across planning, execution, and delivery while maintaining strong ownership and limited supervision.

Key responsibilities

• Manage program execution rigor, including integrated schedules, dependencies, risks, issues, and clear escalation pathways.
• Own sustainment program management for hardware, SaMD, and connected digital platforms, ensuring safety, effectiveness, compliance, and commercial viability.
• Drive roadmap clarity and execution for minor enhancements, defect remediation, cybersecurity updates, and regulatory‑driven changes.
• Implement detailed program plans covering timelines, resources, risk management, and cross‑functional dependencies.
• Partner with Quality, Regulatory, Clinical, and Post‑Market Surveillance teams to monitor field performance and apply structured risk assessments (e.g., ISO 14971).
• Ensure adherence to FDA 21 CFR Part 820, ISO 13485, IEC 62304, and related cybersecurity and data‑privacy requirements.

Required profile

• 7+ years of software medical device product development or program/project management experience with significant exposure to sustainment or lifecycle management.
• Bachelor’s or master’s degree in Business Administration, Project Management or related field, or equivalent 9+ years of experience.
• Excellent communicator and influencer capable of aligning diverse stakeholders in a matrixed organization.

Required skills

• ISO 13485
• IEC 62304
• ISO 14971
• FDA 21 CFR Part 820/QMSR
• SaMD and connected medical device experience
• Post‑market surveillance, complaint handling, CAPA processes

What we offer

• Competitive salary range $136,000‑$216,000 USD per year.
• Annual incentive bonus and long‑term incentive opportunities.
• Comprehensive benefits including generous PTO, 401k match up to 7%, HSA contributions, stock purchase plan, and education reimbursement.
• Opportunity to work for a global health‑technology leader focused on improving lives.