The Mechanical Engineer is responsible for strong fundamental project management expertise coupled with comprehensive technical knowledge of combination medical device development, validation, transfer to manufacture, and the regulatory approval process. They will need previous direct experience in the complete development life cycle from feasibility through commercialization and a strong character to drive projects to completion.
REQUIRED EXPERIENCE & SKILLS:
5+ years of experience as Mechanical Engineer developing medical devices
5+ years of experience with mechanical design using SolidWorks
Experience with medical device development life cycle and manufacturing
Experience with Design Controls, FDA QSR 21 CFR Part 820, and ISO 13485
Experience with regulatory filings such as 510k, De Novo 510k, & PMA
Experience with FEA simulation
Experience with design for manufacturing
BS in Mechanical or Biomedical Engineering
DESIRED EXPERIENCE & SKILLS:
Experience with injection molding
Experience with computational fluid dynamics (CFD)
Experience with statistical process control (SPC) and design of experiments (DOE)
Competitive compensation and relocation is available for this position.
Please contact us for additional details and to discuss position.
**NO SPONSORSHIP IS AVAILABLE FOR THIS POSITION**
Kui Melendez- Senior Technical Recruiter
Chat Now: Click Here
Job ID: #1685