Senior Technical Program Manager, Hardware

About the role

Hike Medical | San Francisco

About the Role

Hike designs custom medical devices and the AI-driven pipeline and factory that make them. This role owns the programs that take those devices from concept to scaled production.

You will run product development programs across hardware, software, and manufacturing. That includes defining requirements with clinical and biomechanics experts, getting designs to freeze, through verification and validation, and into ramps. Every Hike device is made for one patient from a scan. So your "product" is the full system: the scan capture, the design automation that turns a foot into geometry, the printed device, and the factory process that delivers it at volume.

You will be the technical link between R&D, AI/software, clinical, quality, and the factory floor. You will report to and work directly with leadership, and own each program from concept through sustaining.

What You'll Do

Product Development Program Management

• Own device programs from concept and requirements through Proto, EVT, DVT, PVT, launch, and sustaining
• Turn clinical and biomechanical needs into product requirements and engineering specs, with traceability from user needs through design inputs, outputs, and verification
• Run design reviews, design freeze, and phase-gate exit reviews with clear, measurable entry and exit criteria
• Coordinate work across mechanical, clinical, software, and customer teams; own integrated schedules, dependencies, and the critical path
• Drive system-level tradeoffs between clinical performance, comfort, durability, cost, and lead time, and document the decisions
• Own product roadmap execution as Hike expands from insoles into braces, other DME devices, and eventually powered orthotic and prosthetic devices
• Own BOM, engineering change orders and notices (ECO/ECN), and configuration control in PLM
• Plan and run verification testing: mechanical and fatigue testing, compression set, hardness, dimensional accuracy against the scan, and wear and durability testing (e.g. ASTM D3574, D2240, D395)

Manufacturing Readiness & Scale

• Drive design for manufacturing and assembly (DFM/DFA) and design for additive manufacturing so devices build at yield, cost, and volume
• Partner with manufacturing engineering on process development, validation (IQ/OQ/PQ), and process failure mode analysis (PFMEA) for additive, post-processing, and finishing steps
• Own capex equipment and automation programs at the program level: requirements, business case, vendor selection, factory and site acceptance testing (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

Program Leadership

• Keep 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 drive decisions on schedule, cost, and scope
• Build the product development process, gate model, and tools Hike will scale on

What You Bring

• 10+ years in hardware product development, with 5+ as an EPM or TPM owning programs from concept to mass production
• Shipped multiple products through full NPI (EVT, DVT, PVT), ideally including at least one regulated medical device
• Experience running hardware programs from Proto to Launch
• Strong grasp of requirements management, traceability, and planning
• Working knowledge of polymers, foams, elastomers, and composites, including how material properties affect performance, processing, and durability
• Familiar with additive manufacturing (e.g. MJF, SLS, FDM, DLP) and its design and process constraints; experience with lattice or parametric design is a plus
• Working command of design of experiments (DOE), statistical process control (SPC), failure mode analysis (DFMEA and 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, and clear communication with executives
• BS in Mechanical, Biomedical, Materials, or Manufacturing Engineering, or a related field
• Willing to travel up to 15% to suppliers, CMs, clinics, and equipment vendors

What We Look for

• You are among the best at what you do. You bring deep technical judgment, and you raise the bar for the team around you.
• You make decisive, data-driven calls at the pace the program demands. You know when the data is enough to act, you move programs forward, and you adjust quickly as new data comes in.
• You sustain a high pace and high standards every day, through every build, launch, and ramp.
• You run programs like an owner. You go deep on the technical details, not just the tracker.
• You're resourceful, move quickly, and enjoy building systems from scratch
• You don't need excessive process to produce great outcomes
• You have experience at a high-growth startup, building processes and teams while shipping product

Nice to Have

• Background in soft goods, or wearables
• Experience with mass customization 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) programs
• Exposure to smart manufacturing: machine vision, manufacturing execution systems (MES), in-line data collection

Why Hike

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