Website Johnson & Johnson
This position for an R&D Product Development Engineer is for the Surgeon Response Group (SRG), within the Research and Development (R&D) organization. We are located in West Chester, PA.
Our mission in SRG is to support the hospitals and surgeons who use our product every single day. This position is focused on the development of new, customized medical devices based on a request from a surgeon. In this position, you will engage with customers to design and develop new instrumentation for orthopedic procedures supporting the DePuy Synthes Trauma and CMF portfolios.
- Technically lead all aspects of the design process, including the identification of regulatory needs, developing design specifications, mitigating product risks, and building the engineering design history file.
- Engage with surgeons and sales consultants to define user needs and design inputs.
- Solve design problems utilizing CAD techniques, rapid and conventional prototyping and other available technologies.
- Develop layouts and tolerance studies utilizing GD&T, and will participate in performing design evaluations (such as FEA, simulated use testing, dry labs and wet tissue labs etc.)
- Work with manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes.
- Perform complaint and field investigations supporting patient and customer safety
- Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.
Qualification & Experience:
- BS in engineering is required
- Mechanical Engineering or Biomedical Engineering is preferred
- MS degree preferred
- Minimum of 2 years of experience in designing and producing mechanical products or medical devices
- Experience with CAD software (Pro-E, Creo, Solidworks, etc.) is necessary
- Experience in medical device industry and knowledge of Regulatory Design Controls is desirable
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: PA, US
Application Deadline: N/A