Hardware Operations Manager

Ovii's Interpretation of the Role

The Hardware Operations Manager leads end‑to‑end hardware NPI programs, integrates software platforms with devices, and drives cost‑effective, regulatory‑compliant delivery. This hybrid San Francisco role partners with cross‑functional teams across the US and Asia to ensure high‑quality hardware products for the company’s digital health platform.

Role Snapshot

• Lead hardware NPI programs from concept to launch
• Drive cross‑functional integration of hardware and software
• Manage cost, quality, and regulatory compliance
• Report program metrics and risks to senior leadership
• Champion process improvements in hardware operations

Must-Have Requirements

• hardware operations
• technical program management
• hardware/software integration
• cross‑functional team leadership
• cost optimization
• Bachelor’s degree in engineering, supply chain, or related technical field

Nice-to-Have Signals

• master’s degree
• medical‑device industry experience
• Agile or Lean methodologies
• familiarity with FDA and ISO 13485 regulatory requirements
• medical device industry
• Agile/Lean methodologies
• Master’s degree in engineering, business, or related field

Work Setup

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

Not Specified in JD

• Visa sponsorship
• Salary range
• Remote eligibility
• Travel requirement
• Security clearance
• Coding test

What You'll Likely Work On

• Own end‑to‑end hardware NPI initiatives, ensuring launch and sustaining phases meet medical‑device regulations.
• Create and execute strategic roadmaps that align hardware, software, supply‑chain, and regulatory teams across the US and Asia.
• Lead integration of software platforms with hardware products, collaborating closely with engineering and product stakeholders.
• Track, analyze, and present key program metrics, risks, and milestones to senior leadership.
• Identify and implement cost‑optimization opportunities without sacrificing quality or schedule.
• Promote best‑practice processes and continuous improvement within hardware operations.

Good Fit If You Have

• Experience in the medical‑device or digital‑health industry.
• Comfort working with US‑ and Asia‑based stakeholders.
• Thrives in a high‑growth, fast‑paced environment.
• Strong analytical and problem‑solving abilities.
• Excellent verbal and written communication skills.