Sr. Product Engineer; Medical Devices

Our client is seeking an experienced R&D-focused engineer or program specialist with strong SaMD (Software as a Medical Device) and medical device hardware experience. This individual will support a fast‑paced engineering environment, managing updates to both hardware and software products while working closely with product, engineering, and manufacturing partners. The ideal candidate has a proven ability to deliver projects on time, assess technical risks, understand testing requirements, and navigate supply chain, contract manufacturing, and post‑market optimization.

This role requires someone who has seen products through full lifecycle in a variety of different positions, with strong ability to hit deadlines, work in a fast paced environment and has strong communication skills.

• Manage and execute adjustments to product hardware, accessories, and software releases.
• Evaluate project predictability: margin of error, delivery accuracy, timeline adherence, and overall success metrics.
• Operate in a highly fast‑paced environment with aggressive timelines and shifting priorities.
• Partner with product teams, SAE groups, and chapter leads on planning activities and release readiness.
• Participate in planning discussions to determine project type (e.g., maintenance release vs. new feature).

• Work directly with contract manufacturers to ensure product updates are executed effectively.
• Support optimization and maintenance updates for existing critical hardware.
• Coordinate testing of new accessories, ensuring regressions are caught and documentation is accurate.
• Understand differences between hardware testing, software testing, system integration, and regression validation.
• Collaborate with software engineers developing the operating system‑level software to be installed on devices.

• Support ecosystem platform updates where delivery timelines are often as short as 30 days.
• Provide input on realistic delivery expectations: concept → release.
• Work cross‑functionally to understand requirements behind software maintenance releases and feature updates.

• 7+ years of Project Management experience
• 3+ years working specifically with medical devices (SaMD or hardware)
• Proven ability to deliver projects with tight deadlines in a fast‑paced environment
• Experience collaborating with contract manufacturers
• Strong understanding of testing fundamentals (hardware, software, regression, documentation)
• Familiarity with supply chain dependencies
• Experience working cross‑functionally with product, engineering, and quality