Program Manager
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Job Description
A leading medtech organization is seeking a Program Manager with deep medical device development experience to lead an active urology‑based stimulator program. This role requires hands-on leadership in software development, cross-functional engineering coordination, and Agile program execution within a regulated environment.
About the Program
- Software-driven urology stimulator device
- Ongoing software development (team of ~4 developers, ~5 months remaining)
- Verification team of ~3 engineers (~4 months)
- Electrical engineering support (~1.5 resources for 2–3 months)
- Internal resources already in place
- Mid-maturity Agile environment in need of strengthened structure and discipline
Key Responsibilities
Program Leadership
- Lead a cross-functional medical device development program spanning software, verification, and electrical engineering.
- Provide support and backup to Systems Engineering as needed.
- Coordinate engineering resources to maintain alignment, momentum, and accountability.
- Ensure program deliverables meet design control and medical device development requirements.
Agile Execution (Scrum Master Responsibilities)
- Break down epics into actionable user stories.
- Facilitate sprint planning, backlog grooming, reviews, and retrospectives.
- Track team velocity and enforce sprint discipline.
- Drive consistent Agile practices within a regulated hybrid Agile–Waterfall framework.
- Integrate Agile execution into the broader medical device lifecycle.
Verification & Compliance
- Coordinate execution of verification and validation (V&V) activities.
- Maintain alignment with the organization’s QMS and documentation processes.
- Ensure proper handling of design control artifacts including requirements traceability, risk management, and verification protocols.
Cross-Functional Coordination
- Collaborate closely with software development, systems engineering, verification, and electrical teams.
- Maintain program cadence and execution rigor across all functions.
- Serve as the program’s execution driver — not simply a status reporter.
Required Qualifications
- 10+ years of medical device development experience
- 5+ years in Program Management
- Strong background leading software-heavy medical device programs
- Experience serving as a Scrum Master within regulated environments
- Strong working knowledge of:
- Medical Device QMS
- Design Controls
- Verification & Validation (V&V)
- Requirements traceability
- Engineering background preferred (Systems, Software, Electrical, etc.)
- Experience running Agile within a Waterfall product lifecycle
- Comfortable working in a mid-maturity Agile environment and able to enforce structure
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Contact: rbakeoven@judge.comAutomate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.