Senior Program Manager (Medical Devices)

Location: United States, with locations listed as Boston and San Francisco; travel up to 15% to suppliers, contract manufacturers, clinics, and equipment vendors.

Salary: $150,000–$230,000 per annum.

Company

Well-funded, fast-growing healthtech startup developing patient-specific medical devices and expanding from insoles to braces, DME, powered orthotic, and prosthetic devices.

What you will do

• Own hardware device programmes from concept and requirements through Proto, EVT, DVT, PVT, launch, and sustaining.
• Translate clinical and biomechanical needs into product requirements and engineering specifications, maintaining traceability through design inputs, outputs, and verification.
• Lead design reviews, design freezes, phase-gate exits, integrated schedules, dependencies, critical paths, and system-level tradeoffs.
• Drive manufacturing readiness, DFM/DFA, additive manufacturing processes, pilot builds, supplier and contract manufacturer coordination, and production scale-up.
• Own capex equipment and automation programmes, including requirements, business cases, vendor selection, FAT/SAT, and qualification.
• Lead technical risk management, root-cause and failure analysis, executive reporting, and development of scalable product and programme processes.

Requirements

• 10+ years in hardware product development, including 5+ years as an EPM or TPM owning programmes from concept to mass production.
• Multiple products shipped through full NPI, including EVT, DVT, and PVT; experience with hardware programmes from Proto to Launch and ideally at least one regulated medical device.
• Strong requirements management, traceability, planning, scheduling, risk management, escalation, and executive communication skills.
• Working knowledge of polymers, foams, elastomers, and composites, including their effects on performance, processing, and durability.
• Familiarity with additive manufacturing technologies including MJF, SLS, FDM, and DLP, plus their design and process constraints.
• Working command of DOE, SPC, DFMEA, PFMEA, structured root-cause analysis, IQ/OQ/PQ validation, and verification testing.
• Experience leading cross-functional teams to quality, cost, and schedule targets without direct authority.
• BS in Mechanical, Biomedical, Materials, Manufacturing Engineering, or a related field.
• Technical depth, sound judgment, decisive data-driven decision-making, ownership, resourcefulness, and experience building processes and teams in a high-growth startup.

Nice to have

• Background in soft goods or wearables.
• Experience with mass customisation or patient-specific devices.
• Experience with electromechanical or powered medical devices, including sensors, actuators, batteries, or IEC 60601.
• Experience with FDA submissions, 510(k) or exemption strategy, or HCPCS/DME reimbursement programmes.
• Exposure to smart manufacturing, including machine vision, MES, and in-line data collection.
• Experience with lattice or parametric design.

Culture & Benefits

• Own both the product and the factory that makes it.
• Work directly with leadership on company-defining programmes.
• Build the hardware programme function at an early-stage medical device company.
• Travel up to 15% for suppliers, contract manufacturers, clinics, and equipment vendors.
• Accessibility adjustments are available throughout the application and interview process.