TriMed, Inc., is currently seeking a Senior Engineer to join our team in our Valencia office. The Sr. Engineer will design and develop implants for lower and upper extremities and instrumentation. This position must ensure that the development and distribution of medical products are in accordance with corporate policies, including compliance with FDA, ISO 13485 and the Medical Device Directive.
Duties & Responsibilities
- Work with Product Managers and other team members in developing new products.
- Research & Development of upper and lower extremity implant and instrumentation.
- Review of DCO.
- 510(k) submissions.
- Design and maintain test machines and fixtures.
- Lead product testing in design verification and validation activities.
- Lead design control and risk management.
- Maintain DHR (Design History Records) and Engineering data required for FDA submissions.
- Work with vendors to produce instruments and/or components for implants.
- Must have minimum 7-10 years’ experience in the orthopedic implant and instrument design experience.
- Bachelor of Science in Mechanical Engineering or Engineering; Masters Preferred.
- Strong design control experience.
- Supervisor/Project Manager experience.
- Regulatory affairs experience.
- Expertise with parametric CAD design package.
- Must be proficient at Solidworks.
- Working knowledge with FDA regulations.
- Must be familiar with design controls and risk management.
- Must be self-motivated and have excellent prioritization and project development skills.
- Proven experience with writing and compiling technical files.
- Candidate should have a hands-on approach and the capability to work independently.