If you are looking for a contract that will get you through the holidays and well into Q1 of 2019 and you have a background in Device Engineering, Quality, and/or Regulatory Documentation, this is the role you may be looking for. Our client is in the Orthopedic space and looking for expertise in Design Assurance and DHF documentation to assist them as they move toward approvals.
Your understanding of how, when, and why the right paperwork is critical at various points in the stage-gate process is crucial but your ability to work with engineering (cross-functionally) and ensure the documents are right is equally as important. Of course, this also means you’ll be involved with other requirements of the DHF including ECO’s.
- Demonstrable knowledge of Design Control/DHF documents including FMEA’s, V&V, DOE, Design Input/output
- Knowledgeable in the requirements of various notified bodies including FDA, EU, PMDA, etc.
- Thorough understanding of how to interact with cross-functional teams from concept to commercialization
- Experience with project/time management tools
- Understanding of GD&T usage and interpretation
- Experience with SolidWorks a significant plus
- The willingness to contribute to the team by wearing different hats every day while staying focused on the objective
- Familiarity with the application (i.e. anatomical) and manufacture of orthopedic implants a plus
- BS in Mechanical or Biomedical Engineering
- of 2 and up to 5 years’ demonstrable experience in device development, and/or quality, preferably in an orthopedic application