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.
About the job
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 Operations, Technical Program Management, Npi, Cross-Functional Team Management, Software Platform Integration, Hardware/Software Integration, Supply Chain, Regulatory Compliance, Fda, Iso 13485, Agile, Lean Methodologies
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