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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