Senior Technical Program Manager, Hardware

The role

You will own product development programs from concept to scaled production across hardware, software, and manufacturing. You will act as the technical link between R&D, AI, clinical, quality, and the factory floor.

What you will do

• 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
• Run design reviews, design freeze, and phase-gate exit reviews
• Coordinate work across mechanical, clinical, software, and customer teams
• Drive system-level tradeoffs between clinical performance, comfort, durability, cost, and lead time
• Own product roadmap execution
• Own BOM, engineering change orders and notices, and configuration control in PLM
• Plan and run verification testing
• Drive design for manufacturing and assembly and design for additive manufacturing
• Partner with manufacturing engineering on process development, validation, and PFMEA

Required qualifications

• 10+ years in hardware product development
• 5+ years as an EPM or TPM owning programs from concept to mass production
• Shipped multiple products through full NPI (EVT, DVT, PVT)
• Experience running hardware programs from Proto to Launch
• Strong grasp of requirements management, traceability, and planning
• Working knowledge of polymers, foams, elastomers, and composites
• Familiar with additive manufacturing (e.g. MJF, SLS, FDM, DLP)
• 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
• BS in Mechanical, Biomedical, Materials, or Manufacturing Engineering, or a related field

Nice to have

• 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 (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

Benefits

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

About the company

Hike Medical is building the defining company in musculoskeletal care, operating at the intersection of AI, robotics, and healthcare. They have raised $22M through Seed and Series A.