The Senior Design Engineer is responsible for leading new product development initiatives. This position will be a subject matter expert on new product design and 3D modeling and will be responsible for working with our Shanghai sourcing teams and Asian vendors to develop new medical devices and insure that project timelines and requirements are met.
Core job responsibilities:
1. Design and develop new medical devices for sale into international markets.
2. Develop design specifications, manage multiple project timelines, and balance corporate priorities for product development projects to ensure that deadlines and goals are being met.
3. Collaborate with sourcing teams and manufacturers to identify design requirements and assist in product development.
4. Conduct risk assessments on proposed designs and implement mitigating factors
5. Support new product implementation and troubleshoot problems that arise
6. Work with legal to design and implement new Intellectual Property
7. Review existing products and recommend improvements based on existing complaints, risk analyses, manufacturer feedback, cost saving opportunities, etc
1. Minimum BS in mechanical engineering, biomedical engineering
2. 5 + years of experience in new product development/manufacturing within the medical device industry
3. Hands-on experience on injection molding, extrusion, blow molding, and other common plastic manufacturing processes
4. Familiar with common plastic and metal materials.
5. Experience with Solidworks software and prototype fabrication; Certified solidworks expert preferred
6. Experience with project management
7. Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process
8. Have successfully designed and helped launch at least one medical device to market
9. Experience in mentoring and training lower level employees.