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Hinge HealthHinge HealthSan Francisco, CA

Hardware Operations Manager

Lead hardware NPI programs and sustain engineering for medical devices, managing cross-functional teams across US and Asia while integrating software platforms with hardware products. Requires 5+ years in hardware operations or TPM and a bachelor's in engineering or related field.

156k – 234k/yr
Hybrid5+ YOEHardware Engineering

About the role

What you will accomplish

  • Lead end-to-end hardware technical NPI programs from concept through launch and into sustaining phases as per the regulatory standards of medical devices
  • Develop and execute strategic and tactical roadmaps that align with the business vision and objectives across cross-functional teams of HW Eng, SW Eng, supply chain, regulatory across US and Asia
  • Experience with leading implementation and integration of software platforms with hardware products, collaborating with software engineering and functional stakeholders
  • Monitor and report on key program metrics, risks, and milestones to senior leadership
  • Drive cost optimization initiatives without compromising quality or delivery timelines
  • Champion process improvements and best practices in hardware operations and program management

Basic Qualifications

  • 5+ years of experience in hardware operations, technical program management, or related fields
  • 3+ years of experience managing cross-functional teams and projects in a hardware/software environment
  • 3+ years of experience in software platform implementation and integration with hardware
  • Bachelor’s degree in engineering, supply chain, or a related technical field

Preferred Qualifications

  • Master’s degree in engineering, business, or related field
  • Experience in the medical device or digital health industry
  • Familiarity with regulatory requirements (e.g., FDA, ISO 13485) for hardware products
  • Experience with Agile or Lean methodologies in hardware development
  • Proven track record of delivering complex hardware products on time and within budget
  • Demonstrated ability to lead programs involving US and Asia-based stakeholders
  • Strong analytical and problem-solving skills
  • Excellent verbal and written communication skills
  • Experience working in a high-growth, fast-paced environment

Skills

Hardware OperationsTechnical Program ManagementNpiCross-Functional Team ManagementSoftware Platform IntegrationHardware/Software IntegrationSupply ChainRegulatory ComplianceFdaIso 13485AgileLean Methodologies
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