The Role

As one of Fareon’s earliest hires, the Senior Technical Program Manager will own execution of our most important programs, keeping them on schedule, on budget, and visible to everyone who depends on them. This individual will work directly with the Chief Product Officer to lead two parallel streams of work: the manufacturing ramp of our delivery system and the development of our companion software applications. This person will own the Design History File for Fareon’s delivery system and lead design transfer to our contract manufacturer. The role will also initially have a dotted line to the Head of Research, with ~25% of time spent supporting projects in the Fareon lab, including grant-supported programs.

This is a hands-on role in a three-person company that is about to grow significantly. The TPM will be expected to build the lightweight processes, tools, and reporting rhythms that let a small team execute like a much larger one. Task scope will range from high-level strategy and long-term planning to shipping and service. The right candidate works independently, communicates crisply, and is energized rather than unsettled by a dynamic environment where priorities evolve as the company learns.

Priorities for the first six months are, in order: (1) the Design History File, complete and audit-ready through design transfer, (2) the manufacturing ramp with our contract manufacturer, and (3) establishing the delivery cadence for our companion software products. Lab and grant support, process buildout, and board reporting are real responsibilities, but they are sequenced behind these three.

As Fareon grows, so does this role. The Senior Technical Program Manager position is designed to expand with the company, with a clear path to leading the program management function, including hiring and developing program staff, as our clinical, engineering, and manufacturing programs scale.

You will be based in San Francisco, CA and work a hybrid schedule with up to three days per week in our office and lab in Potrero Hill.

Responsibilities

Oversight of Medical Device Design Control Processes

• Assume ownership of the Design History File for Fareon’s delivery system, and serve as design control lead through design transfer and marketing authorization
• Organize and run stage gate reviews, capturing decisions and maintaining action item logs
• Coordinate external resources to execute on required testing to support device registration
• Keep program records audit-ready, and serve as the program-level point of contact for our regulatory and quality lead during audits and submission preparation

Manufacturing Ramp and Design Transfer

• Lead Fareon’s manufacturing ramp, tracking schedules, deliverables, and dependencies across contract manufacturers, component suppliers, and external engineering partners
• Lead design transfer to our contract manufacturer, including transfer of specifications, process documentation, and acceptance criteria, through first production lot
• Maintain the integrated manufacturing timeline, flag risks early, and drive open issues to closure
• Serve as a day-to-day coordination point for external vendors and contractors, tracking statements of work, deliverables, and invoices against plan, and escalating when commitments slip

Software Development Program Management

• Manage the execution of current and future software application development projects, including a patient-facing mobile app, trial coordinator dashboard, and fleet management system
• Coordinate with external development teams, track milestones against plan, and make sure requirements, decisions, and changes are documented

Lab and Grant Program Support

• Assist our scientific leadership in managing projects in the Fareon lab, including planning experiments and studies as projects with timelines, resources, and deliverables
• For grant-supported work, track milestones, budgets, and reporting deadlines so that every deliverable and report is delivered on time

Develop Processes and Tools

• In cooperation with CPO, establish a project management toolkit for the company, including templates, trackers, and meeting rhythms
• Build and maintain simple, durable program dashboards and status reporting
• Prepare program summaries for board, investor, and grant-related updates as needed
• Leverage approved AI tools to multiply your effectiveness
• Support fundraising and strategic diligence activities as requested
• As the team grows, hire, mentor, and develop program management staff

A Little Bit of Everything Else When Needed

• Test, pack, and ship devices
• Debug/repair/refurbish devices in the field remotely and in person
• Other unanticipated technical and quasi-technical tasks that might arise

What success in the first 12-24 months looks like:

• Design History File audit-ready and design transfer complete through first production lot
• Tools and processes implemented to provide up-to-date insight into project status
• Smooth running communications with manufacturing partner
• Companion software products delivered on a predictable cadence with documented requirements and change history
• Several opportunities identified for process improvement, with implementation completed
• Proactive expansion of responsibilities based on observation of need

Required Qualifications

• Bachelor’s degree in technical field relevant to Fareon’s work, preferably an engineering discipline
• 6–12 years of program or project management experience in a technical, fast-moving environment, such as 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)
• Has 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 a strong sense of ownership
• Experience coordinating external partners, such as contract manufacturers, engineering firms, or software development vendors
• Fluency with modern project management and collaboration tools, and comfort using approved AI tools to work faster and smarter
• Exceptional organizational skills and attention to detail, paired with the judgment to distinguish what matters from what merely looks urgent
• Excellent written and verbal communication, including the ability to distill complex, cross-disciplinary programs into clear status for executives and partners
• Comfort operating in a startup environment where you will be both process builder and hands-on contributor, and where the plan will change as the company learns

Preferred Qualifications

• Experience with clinical-stage device programs, including trial device supply, field support, and coordination with clinical operations
• Experience supporting grant-funded research, including milestone and budget reporting to federal or foundation sponsors
• Familiarity with software development practices sufficient to run an effective cadence with engineering teams
• Familiarity with medical device software standards such as IEC 62304
• PMP, PgMP, or similar certification is welcome but is not a substitute for practical, hands-on program execution

Opportunities for Growth and Advancement

Fareon is at the beginning of its scaling journey. Compensation will be Bay Area competitive, including full benefits and equity. The person who takes this role and excels will be positioned to lead program management across our clinical, engineering, and manufacturing programs, including building the team, as the organization expands.