Role OverviewThe Product Development Lead will spearhead the design, development, and launch of cutting-edge medical device and drug delivery solutions, working closely with customers and cross-functional teams.
What You Will Do
Lead the technical direction and execution of medical device and drug delivery projects from concept through launch, collaborate with customers and teams, and oversee system architecture and compliance with industry standards.
Why It Might Be a Fit
The ideal candidate will have experience in medical device design/development, technical leadership, and regulatory compliance, with strong leadership and project management skills.
Requirements
- Bachelor’s Degree or higher in Biomedical, Electrical, Mechanical, or Biological Engineering
- 5+ years’ experience in medical device design/development, with 3+ years in technical leadership
- Experience with FDA Class II/III devices, design controls, risk management (ISO 14971), and validation
- Familiarity with FDA 21 CFR Part 820, ISO 13485, IEC 62304, IEC 60601
- Experience supporting development of regulatory submission documentation packages
- Experience working with multiple, diverse quality management systems
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Flexible spending and health savings accounts
- Life insurance
- ADD
- Disability
- Retirement
- Paid vacation/time off
- Educational assistance
- Infertility assistance
- Paid parental leave
- Adoption assistance
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