Senior Hardware TPM for Medical Devices

Hike Medical Inc.

San Francisco (CA)

On-site

USD 180,000 - 240,000

Full time

14 days+

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Job summary

Hike Medical in San Francisco seeks a Senior Technical Program Manager, Hardware, to lead end-to-end development programs for our AI-driven, custom medical devices, spanning hardware, software, and manufacturing. You will translate clinical and biomechanics needs into requirements, drive design reviews, and manage schedules, risks, and vendor partnerships as we scale from insoles to braces and orthotics.

You will report to leadership and influence product roadmaps.

Qualifications

  • 10+ years in hardware product development or related field.
  • Experience leading hardware programs from Proto to Launch.
  • Strong requirements management and traceability.
  • Experience with additive manufacturing and DFx principles.

Responsibilities

  • Own device programs from concept through EVT/DVT/PVT, launch, and sustaining.
  • Translate clinical and biomechanics needs into engineering specs with traceability.
  • Lead design reviews and phase-gate exits with clear criteria.
  • Coordinate cross-functional work across mechanical, software, clinical, and manufacturing teams.
  • Drive system-level tradeoffs among performance, comfort, durability, cost, and lead time.
  • Own roadmap execution as products expand to new DME and powered devices.
  • Plan and run verification testing per standards.
  • Maintain live risk register and mitigate risks.

Skills

Hardware product development
Program management
NPI process
Requirements management
Additive manufacturing
DFM/ DFA
DOE / SPC / FMEA
Cross-functional leadership
Vendor management
Travel willingness

Education

BS in Mechanical/ Biomedical/ Materials/ Manufacturing Engineering

Tools

PLM software
Statistical analysis tools

Job description

Hike Medical in San Francisco seeks a Senior Technical Program Manager, Hardware, to lead end-to-end development programs for our AI-driven, custom medical devices, spanning hardware, software, and manufacturing. You will translate clinical and biomechanics needs into requirements, drive design reviews, and manage schedules, risks, and vendor partnerships as we scale from insoles to braces and orthotics.

You will report to leadership and influence product roadmaps.

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