Leading structured sustainment programs aligned to organizational goals
Providing end-to-end governance across planning, execution, and delivery
Managing program execution rigor, including integrated schedules, dependencies, risks, and issue tracking
Providing transparent reporting to leadership on scope, timelines, quality, and compliance
Owning the sustainment program management for a portfolio of medical devices
Ensuring products in the field remain safe, effective, compliant, and commercially viable throughout the full lifecycle
Driving roadmap clarity and execution for sustainment initiatives such as minor enhancements, defect remediation, cybersecurity updates, and regulatory-driven changes
Implementing and managing detailed program plans covering timelines, resourcing, risk management, and cross-functional dependencies
Monitoring performance using KPIs such as schedule and cost variance
Partnering cross-functionally with Quality, Regulatory, Clinical, and Post‑Market Surveillance teams to monitor field performance and manage risk

Requirements

7+ years of software medical device Product development and/or Program or Project Management experience
Hands-on experience managing products in-market including post-market surveillance, complaint handling /CAPA and sustenance releases (patches, updates, minor features)
Strong knowledge of medical device regulations and standards including ISO 13485, IEC 62304, ISO 14971
Experience with SaMD and/or connected medical devices is highly preferred.

Benefits

Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

program managementrisk managementissue trackingKPI monitoringproduct developmentpost-market surveillancecomplaint handlingCAPAsustenance releasesregulatory compliance

Soft Skills

leadershipcommunicationcross-functional collaborationorganizational skillstransparency in reporting