Expert Technical Program Manager, AI Medical Hardware Products (Hybrid/Remote)
Related skills
ai iso 13485 automation regulatory compliance eu mdr📋 Description
- Own cross-functional NPI programs from concept through launch.
- Lead cross-functional execution across Eng, Process Dev, CI, Design Transfer, Supply Chain, QARA.
- Drive contract manufacturer selection, onboarding, and qualification timelines.
- Help regulatory submissions with QARA, tracking milestones and readiness.
- Establish governance for product development, design reviews, and risk mgmt.
- Define standardized protocols for contract manufacturer regulatory and quality matters.
🎯 Requirements
- Bachelor's or Master's in Biomedical, Mechanical, Electrical Engineering or related field.
- 5+ years in program management or tech leadership in medical devices.
- 5+ years leading cross-functional NPI programs or technical projects.
- Product Life Cycle Management experience with process optimization.
- Strong regulatory knowledge: FDA 21 CFR 820, ISO 13485, EU MDR.
- Proven track record leading contract manufacturer qualification and onboarding programs.
🎁 Benefits
- Health, dental and vision insurance
- Meal allowance
- Equity shares
- Remote work allowance
- Flexible working hours
- Work from home
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