Senior Program Manager
Location
Boston, San Francisco, United States
Salary
$180000 - 230000 - Per Annum
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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