Senior Technical Program Manager, Hardware

Hike Medical•San Francisco, CA

About The Position

Hike Medical is hiring a Senior Technical Program Manager to own programs that take custom medical devices from concept to scaled production. The role manages product development programs across hardware, software, and manufacturing, translating clinical and biomechanical needs into requirements, guiding designs through design freeze and verification and validation, and supporting production ramps. Because each device is made for an individual patient from a scan, the program encompasses the full system: scan capture, automated design, the printed device, and the factory process that delivers it at volume. The position serves as the technical link between R&D, AI/software, clinical, quality, and manufacturing, and reports to and works directly with leadership. It owns programs from concept through sustaining, including product development, manufacturing readiness, scale, risk management, and the development of processes and tools for Hike's hardware program function. Hike is based in San Francisco and describes its culture as fast-paced, results-first, and high-ownership.

Requirements

10+ years of experience in hardware product development, including 5+ years as an EPM or TPM owning programs from concept to mass production.
Experience shipping 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.
Familiarity with additive manufacturing (such as MJF, SLS, FDM, or DLP) and its design and process constraints.
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.
Bachelor's degree in Mechanical, Biomedical, Materials, or Manufacturing Engineering, or a related field.
Willingness to travel up to 15% to suppliers, contract manufacturers, clinics, and equipment vendors.

Nice To Haves

Experience with lattice or parametric design.
Background in soft goods or wearables.
Experience with mass customization 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 reimbursement (HCPCS/DME) programs.
Exposure to smart manufacturing, including machine vision, manufacturing execution systems (MES), or in-line data collection.
Experience at a high-growth startup building processes and teams while shipping products.

Responsibilities

Own device programs 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 from user needs through design inputs, outputs, and verification.
Run design reviews, design freezes, and phase-gate exit reviews with clear, measurable entry and exit criteria.
Coordinate mechanical, clinical, software, and customer teams; own integrated schedules, dependencies, and the critical path.
Drive and document system-level tradeoffs among clinical performance, comfort, durability, cost, and lead time.
Own product roadmap execution as Hike expands into braces, other DME devices, and powered orthotic and prosthetic devices.
Own the BOM, engineering change orders and notices (ECO/ECN), and configuration control in PLM.
Plan and run verification testing, including mechanical and fatigue testing, compression set, hardness, dimensional accuracy against scans, and wear and durability testing.
Drive design for manufacturing and assembly (DFM/DFA) and design for additive manufacturing to achieve production yield, cost, and volume goals.
Partner with manufacturing engineering on process development, IQ/OQ/PQ validation, and PFMEA for additive manufacturing, post-processing, and finishing.
Own program-level capital equipment and automation work, including requirements, business cases, vendor selection, FAT/SAT, and qualification.
Model throughput and capacity for batch-of-one production and identify bottlenecks before the production line is built.
Manage pilot builds, suppliers, and contract manufacturers for non-printed parts.
Maintain a live technical risk register and close or mitigate risks before the next program gate.
Lead root-cause and failure analysis for complex design, material, and process issues.
Report program status to leadership and use data to guide schedule, cost, and scope decisions.
Build the product development process, gate model, and tools that Hike will scale.
Travel up to 15% to suppliers, contract manufacturers, clinics, and equipment vendors.