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Fareon, a three-person medical device company, is seeking a Senior Technical Program Manager to own execution of critical programs as the organization scales. Reporting to the Chief Product Officer, you will lead two parallel workstreams: the manufacturing ramp of Fareon's delivery system and development of companion software applications. You will own the Design History File for the delivery system and lead design transfer to the contract manufacturer. Initially, you will have a dotted-line relationship with the Head of Research, dedicating approximately 25% of your time to supporting lab projects, including grant-funded programs.
This is a hands-on role in a dynamic startup environment. You will build lightweight processes, tools, and reporting cadences that enable a small team to execute with the rigor of a much larger organization. Responsibilities span from high-level strategy and long-term planning to shipping and field service.
Key responsibilities include: owning the Design History File and serving as design control lead through design transfer and regulatory submission; organizing stage-gate reviews and maintaining audit-ready program records; leading the manufacturing ramp with contract manufacturers and component suppliers; managing design transfer including specifications, process documentation, and acceptance criteria; maintaining integrated manufacturing timelines and flagging risks; coordinating with external vendors on statements of work and deliverables; managing current and future software development projects (patient-facing mobile app, trial coordinator dashboard, fleet management system); assisting scientific leadership with lab project planning; tracking grant milestones, budgets, and reporting deadlines; establishing project management toolkits, templates, and dashboards; preparing program summaries for board and investor updates; and supporting fundraising and strategic diligence activities. As the team grows, you will hire, mentor, and develop program management staff.
Success in the first 12–24 months means: Design History File audit-ready and design transfer complete through first production lot; tools and processes implemented for real-time project visibility; smooth manufacturing partner communications; companion software delivered on a predictable cadence with documented requirements and change history; process improvements identified and implemented; and proactive expansion of responsibilities based on observed need.
You will be based in San Francisco (Potrero Hill) and work a hybrid schedule with up to three days per week in the office and lab.
REQUIREMENTS:
- Bachelor's degree in a technical field relevant to the company's work, preferably engineering
- 6–12 years of program or project management experience in a technical, fast-moving environment (medical devices, biotech, hardware, or connected products)
- Hands-on experience maintaining a Design History File through at least one FDA submission; ownership strongly preferred (510(k), De Novo, or PMA)
- Led at least one design transfer to a contract manufacturer operating under ISO 13485
- Demonstrated ability to run multiple concurrent workstreams independently with minimal supervision and strong sense of ownership
- Experience coordinating external partners (contract manufacturers, engineering firms, software development vendors)
- Fluency with modern project management and collaboration tools; comfort using approved AI tools
- Exceptional organizational skills and attention to detail with judgment to distinguish what matters
- Excellent written and verbal communication, including ability to distill complex cross-disciplinary programs into clear executive summaries
- Comfort operating in a startup environment as both process builder and hands-on contributor, where plans evolve as the company learns
PREFERRED QUALIFICATIONS:
- Experience with clinical-stage device programs, including trial device supply, field support, and clinical operations coordination
- Experience supporting grant-funded research, including milestone and budget reporting to federal or foundation sponsors
- Familiarity with software development practices sufficient to run effective engineering cadences
- Familiarity with medical device software standards such as IEC 62304
- PMP, PgMP, or similar certification (not a substitute for practical hands-on experience)
