NPD Engineers
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Key skills for this role
Key Skills for This Role
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Key responsibilities
- Lead end-to-end product development from concept and design through verification, validation, manufacturing transfer, launch, and sustaining.
- Own design control activities, including requirements, risk management, the design history file, and verification and validation.
- Translate user and clinical needs into clear engineering solutions.
- Ensure designs meet performance, safety, manufacturability, and regulatory requirements.
- Partner with Quality, Regulatory, Clinical, Manufacturing, and Marketing teams.
- Support regulatory submissions such as 510(k) submissions and 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.
- NX is identified as the CAD tool.
Required qualifications
- Bachelor’s degree in engineering or science.
- Five to ten years of 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.
Additional experience
- The description mentions experience with bioengineered collagen, extracellular matrix, or tissue-based products, but the source text ends before stating the complete qualification.
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