Key Responsibilities
- Lead end‑to‑end product development: concept, design, verification/validation, manufacturing transfer, launch, and sustaining
- Own design control activities, including requirements, risk management, DHF, and V&V;
- Translate user and clinical needs into explicit engineering solutions
- Ensure designs meet performance, safety, manufacturability, and regulatory requirements
- Partner with Quality, Regulatory, Clinical, Manufacturing, and Marketing teams
- Support regulatory submissions (e.g., 510(k), technical files)
- Manage external vendors and suppliers supporting development and testing
- Support prototyping, testing, and design iteration
- Provide technical leadership and mentorship to junior team members
- CAD Tool : NX
Required Qualifications
- Bachelor’s degree in engineering or science
- 3 to 10 years’ experience in medical device, biotech, or pharmaceutical product development
- Proven experience leading products through the full design control lifecycle
- Experience taking products from concept to commercialization
- Strong communication skills and ability to work in a matrix organization
Experience with bioengineered collagen, ECM, or tissue‑based prod