Senior Program Manager

Job Title: Senior Program Manager

Job type: Permanent

Salary: $150,000 - $230,000

Role Location: United States

The Company

We’re partnering with a well-funded, fast-growing healthtech startup.

The company is backed by well-known venture investors, runs a fast, results-first, high-ownership culture, and is expanding its product range well beyond its first devices.

This is a chance to own the programme function at an early-stage medical device company, with the product and the factory that makes it both within your remit.

Role and Responsibilities

You’ll own device programmes from concept through scaled production. Each device is made for one patient from a scan, so the product is the whole system: scan capture, automated design, the printed device, and the factory process that delivers it. You’ll be the technical link between R&D, software, clinical, quality, and the factory floor, reporting directly to leadership.

Product development programme management

• Run programmes from concept and requirements through Proto, EVT, DVT, PVT, launch, and sustaining
• Translate clinical and biomechanical needs into product requirements and engineering specs, with traceability through design inputs, outputs, and verification
• Lead design reviews, design freeze, and phase-gate exits with clear entry and exit criteria
• Own integrated schedules, dependencies, and the critical path across mechanical, clinical, software, and customer teams
• Drive and document system-level tradeoffs between clinical performance, comfort, durability, cost, and lead time
• Deliver the product roadmap as the range grows from insoles to braces, other DME devices, and eventually powered orthotic and prosthetic devices
• Own BOM, ECO/ECN, and configuration control in PLM
• Plan and run verification testing, including mechanical, fatigue, compression set, hardness, dimensional accuracy, and wear testing against relevant ASTM standards

Manufacturing readiness and scale

• Drive DFM/DFA and design for additive manufacturing so devices build at the right yield, cost, and volume
• Work with manufacturing engineering on process development, IQ/OQ/PQ validation, and PFMEA for additive, post-processing, and finishing steps
• Own capex equipment and automation programmes: requirements, business case, vendor selection, FAT/SAT, and qualification
• Model throughput and capacity for batch-of-one production and find bottlenecks before the line is built
• Manage pilot builds, suppliers, and contract manufacturers for non-printed parts

Programme leadership

• Maintain a live technical risk register and close or mitigate each risk before the next gate
• Lead root cause and failure analysis on complex design, material, and process issues
• Report status to leadership and use data to steer schedule, cost, and scope
• Build the product development process, gate model, and tools the company will scale on

Job Requirements

• 10+ years in hardware product development, including 5+ as an EPM or TPM owning programmes from concept to mass production
• Multiple products shipped through full NPI (EVT, DVT, PVT), ideally including at least one regulated medical device
• Experience running hardware programmes from Proto to Launch
• Strong grasp of requirements management, traceability, and planning
• Working knowledge of polymers, foams, elastomers, and composites, and how material properties affect performance, processing, and durability
• Familiarity with additive manufacturing (MJF, SLS, FDM, DLP) and its design and process constraints; lattice or parametric design is a plus
• Working command of DOE, SPC, DFMEA/PFMEA, and structured root cause analysis
• Track record of leading cross-functional teams to quality, cost, and schedule targets without direct authority
• Strong schedule, risk, and escalation discipline, with clear communication to executives
• BS in Mechanical, Biomedical, Materials, or Manufacturing Engineering, or a related field
• Willing to travel up to 15% to suppliers, contract manufacturers, clinics, and equipment vendors
• Technical depth and sound judgment, and you raise the bar for those around you
• Decisive and data-driven: you know when there’s enough data to act and adjust fast as new information arrives
• Owner mindset: you go deep on technical detail, not just the tracker
• Resourceful and fast-moving, and you enjoy building systems from scratch without heavy process
• Experience at a high-growth startup, building process and teams while shipping product

Nice to have

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

Why join

• Own the product and the factory that makes it, a scope few hardware roles offer
• Direct access to leadership and visibility on company-defining programmes
• Build the hardware programme function at an early-stage medical device company

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