Remote job
Product Manager
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About this role
Role overview A hybrid Product Manager opportunity leading a portfolio of FDA-regulated medical device hardware and firmware products through their full lifecycle. The role sits at the intersection of engineering, clinical, regulatory, quality, and commercial teams, driving products from development through launch, sustainment, and end-of-life planning.
Responsibilities - Serve as primary product owner for hardware and firmware, managing the full lifecycle from concept through launch and post-market improvements - Translate user, customer, and stakeholder needs into clear product requirements and documentation - Partner with engineering, quality, regulatory, clinical, and operations teams to maintain FDA and quality compliance - Lead new product introductions, including launch planning, cross-functional readiness, and performance tracking - Collect usability feedback and market insights to serve as the Voice-of-Customer - Manage ongoing lifecycle activities including improvements, cost reductions, issue resolution, and end-of-life planning
Requirements - 3–5 years of experience as a Product Manager specifically within FDA-regulated medical devices - Demonstrated ability to manage hardware-based products from development through post-market sustainment - Expertise in Design Controls, requirements management, Human Factors Engineering (HFE), and usability studies - Strong Voice-of-Customer research skills and the ability to convert complex problems into actionable data - Proven cross-functional leadership and ability to balance multiple priorities in a fast-paced environment - Clear, structured communication style with a focus on consensus-building
Nice to have - Durable Medical Equipment (DME) experience - Background with wearable medical devices, software-enabled, or connected devices
Benefits and work setup - Hybrid role based in San Mateo, CA, with three days per week on-site (local candidates only) - Full-time, exempt position - Compensation range of $140,000 - $165,000 - Up to 25% travel required