Senior Technical Program Manager, Hardware

San Francisco, CAfull time

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senior

H1B: no

Hike Medical Senior Technical Program Manager, Hardware at Hike Medical to own product development programs from concept through scaled production. The role involves coordinating cross-functional teams and managing design reviews and product roadmap execution.

Responsibilities

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.
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

Qualification

Background in soft goodsExposure to smart manufacturing

Preferred

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
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