Senior Technical Program Manager, Hardware

Senior Technical Program Manager, HardwareHike Medical is building the defining company in musculoskeletal care. We sit at the intersection of AI, robotics, and healthcare, operating across three product lines: a proprietary AI-vision platform that turns a 30-second, web-based foot scan into custom 3D-printed orthotics; an AI agent platform that automates the entire DME workflow from pre-visit processing through claims and revenue cycle; and SoleForge, our vertically integrated 3D-printing factory producing custom medical devices at a scale the industry has never seen.Insoles today, full DME tomorrow, bionics by 2040. Custom insoles are just the wedge. Our long-term vision is bionics: AI-designed, robotically manufactured orthotic and prosthetic devices at scale, replacing a fragmented, manual industry that hasn't changed in decades. Read the full vision at bionics2040.com.We've stealthily raised $22M through Seed and Series A, backed by top-tier investors who backed companies like OpenAI, Anduril, and Mercury early.

We run a fast, results-first, high-ownership culture out of our new SF Rincon Hill office. If you want to work at the frontier of AI, manufacturing, and healthcare, this is the place.About the RoleHike 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 DoProduct Development Program ManagementOwn device programs from concept and requirements through Proto, EVT, DVT, PVT, launch, and sustainingTurn clinical and biomechanical needs into product requirements and engineering specs, with traceability from user needs through design inputs, outputs, and verificationRun design reviews, design freeze, and phase-gate exit reviews with clear, measurable entry and exit criteriaCoordinate work across mechanical, clinical, software, and customer teams; own integrated schedules, dependencies, and the critical pathDrive system-level tradeoffs between clinical performance, comfort, durability, cost, and lead time, and document the decisionsOwn product roadmap execution as Hike expands from insoles into braces, other DME devices, and eventually powered orthotic and prosthetic devicesOwn BOM, engineering change orders and notices (ECO/ECN), and configuration control in PLMPlan 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 & ScaleDrive design for manufacturing and assembly (DFM/DFA) and design for additive manufacturing so devices build at yield, cost, and volumePartner with manufacturing engineering on process development, validation (IQ/OQ/PQ), and process failure mode analysis (PFMEA) for additive, post-processing, and finishing stepsOwn capex equipment and automation programs at the program level: requirements, business case, vendor selection, factory and site acceptance testing (FAT/SAT), and qualificationModel throughput and capacity for batch-of-one production, and find bottlenecks before the line is builtManage pilot builds, suppliers, and contract manufacturers for non-printed partsProgram LeadershipKeep a live technical risk register, and close or mitigate each risk before the next gateLead root cause and failure analysis on complex design, material, and process issuesReport status to leadership, and use data to drive decisions on schedule, cost, and scopeBuild the product development process, gate model, and tools Hike will scale onWhat You Bring10+ years in hardware product development, with 5+ as an EPM or TPM owning programs from concept to mass productionShipped multiple products through full NPI (EVT, DVT, PVT), ideally including at least one regulated medical deviceExperience running hardware programs from Proto to LaunchStrong grasp of requirements management, traceability, and planningWorking knowledge of polymers, foams, elastomers, and composites, including how material properties affect performance, processing, and durabilityFamiliar with additive manufacturing (e.g. MJF, SLS, FDM, DLP) and its design and process constraints; experience with lattice or parametric design is a plusWorking command of design of experiments (DOE), statistical process control (SPC), failure mode analysis (DFMEA and PFMEA), and structured root cause analysisTrack record of leading cross-functional teams to quality, cost, and schedule targets without direct authorityStrong schedule, risk, and escalation discipline, and clear communication with executivesBS in Mechanical, Biomedical, Materials, or Manufacturing Engineering, or a related fieldWilling to travel up to 15% to suppliers, CMs, clinics, and equipment vendorsWhat We Look ForYou 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 scratchYou don't need excessive process to produce great outcomesYou have experience at a high-growth startup, building processes and teams while shipping productNice To HaveBackground in soft goods, or wearablesExperience with mass customization or patient-specific devicesExperience with electromechanical or powered medical devices (sensors, actuators, batteries, IEC 60601)Experience with FDA submissions (510(k) or exemption strategy) or reimbursement (HCPCS/DME) programsExposure to smart manufacturing: machine vision, manufacturing execution systems (MES), in-line data collectionWhy HikeOwn the product and the factory that makes it, a scope few hardware roles offerDirect access to leadership and visibility on company-defining programsBuild the hardware program function at an early-stage medical device company