Overview
Director, Medical Device Program Management Jobs in San Francisco Bay Area at BioTalent
Title: Director, Medical Device Program Management
Company: BioTalent
Location: San Francisco Bay Area
Position can be located on-site in: San Francisco, CA, New York, NY or Boston, MA. Relocation support will be provided for non-local candidates.
Summary
We are looking for a commercially-minded product leader who can bridge consumer health and regulated medical devices, driving strategy from concept through FDA clearance, reimbursement, and market adoption. This is a highly visible role working directly with executive leadership to define and launch a new category of medical products.
Responsibilities:
- Define product strategy, market entry, and commercialization roadmap
- Identify and validate new medical use cases leveraging an existing platform
- Drive FDA pathway strategy (510(k), De Novo) in partnership with internal/external experts
- Shape reimbursement approach and engage with payers
- Translate R&D and engineering capabilities into market-ready medical products
- Drive product definition across hardware, software, and user experience
- Lead programs across engineering, R&D, regulatory, and quality
- Partner closely with executive leadership on business and product strategy
- Test new business models, partnerships, and product concepts
- Balance speed with regulatory and clinical requirements
- Interface with payers, partners, and key stakeholders
- Support go-to-market strategy and ecosystem development
Background Requirements:
- 6+ years of experience in medical devices, digital health, or SaMD
- Knowledge of taking a product through FDA clearance (510(k) or De Novo)
- Knowledge of how to launch a reimbursable medical product
- Strong product management and commercialization mindset (not just program execution)
- Experience working at the intersection of consumer technology and healthcare
- Demonstrated ability to lead cross-functional product development programs
- Exposure to payer strategy, reimbursement, or business development
- Comfortable operating in 0→1 or early-stage environments
- Strong bias for action, ownership, and building from scratch
Ideal Background
- Experience working on consumer-facing health or connected hardware platforms
- Background in wearables, sleep, or continuous monitoring systems
- Exposure to sleep-related conditions or adjacent therapeutic areas preferred
- Experience as a founder, early employee, or high-impact product leader
- Track record of wearing multiple hats across product, strategy, and commercialization
- Strong network of regulatory, clinical, or reimbursement experts
What Success Looks Like
- Define and launch the company’s first medical-grade product offering
- Establish a clear FDA and reimbursement pathway
- Build the foundation for a scalable medical business line
- Bridge consumer user experience with clinical-grade outcomes
