Hardware Operations Manager

Ovii's Interpretation of the Role

The Hardware Operations Manager leads end‑to‑end hardware NPI programs, aligns cross‑functional roadmaps, and ensures regulatory compliance for medical‑device products. The role partners with software, supply‑chain and manufacturing teams across the US and Asia to deliver high‑quality hardware solutions.

Role Snapshot

• Lead hardware NPI programs from concept to launch
• Develop strategic roadmaps across HW, SW, supply chain and regulatory teams
• Integrate software platforms with hardware products
• Monitor program metrics and report to senior leadership
• Drive cost‑optimization while maintaining quality
• Champion process‑improvement and best‑practice adoption

Must-Have Requirements

• hardware operations
• technical program management
• NPI
• cross‑functional team leadership
• software‑hardware integration
• regulatory compliance (FDA, ISO 13485)
• Bachelor’s degree in engineering, supply chain, or related technical field

Nice-to-Have Signals

• master’s degree in engineering or business
• experience in medical‑device or digital‑health industry
• Agile or Lean methodology experience
• high‑growth environment experience
• familiarity with regulatory requirements (FDA, ISO 13485)
• medical device industry
• Agile/Lean methodology
• Master’s degree in engineering, business, or related field
• medical device
• digital health

Work Setup

• Location: San Francisco, USA
• Work mode: HYBRID
• Remote scope: UNSPECIFIED
• Employment type: Full-Time

Not Specified in JD

• Salary range
• Visa sponsorship
• Remote eligibility

What You'll Likely Work On

• Own the full lifecycle of hardware NPI programs, from concept through launch and sustain phases
• Create and execute tactical roadmaps that align hardware, software, supply‑chain and regulatory objectives
• Lead integration of software platforms with hardware products, coordinating US and Asia stakeholders
• Track and communicate program risks, milestones and key metrics to senior leadership
• Identify and implement cost‑saving opportunities without sacrificing quality or schedule
• Establish and refine hardware‑operations processes, applying Agile or Lean best practices

Good Fit If You Have

• Experience in the medical‑device or digital‑health industry
• Familiarity with FDA and ISO 13485 regulatory requirements
• Proven ability to lead programs with US‑ and Asia‑based stakeholders