Sr R&D Process Engineer
Provide mechanical engineering support in creating and developing new medical device products, including invasive and non-invasive solutions. Collaborate with Design, Quality, and Manufacturing teams to integrate new products, equipment sets, or processes into production.
Responsibilities:
1. Research, develop, design, and evaluate mechanical and electro-mechanical materials, components, assemblies, processes, and/or equipment.
2. Conduct feasibility studies to verify capability and functionality.
3. Develop new concepts from initial design to market release.
4. Prepare and submit intellectual property (patents).
5. Maintain detailed documentation throughout all development phases.
6. Collaborate with the Process Development group to design new equipment for new products and manufacturing.
7. Work closely with machine vendors to ensure equipment meets specifications and is properly handed over to manufacturing.
8. Apply technical knowledge to innovate, design, and develop processes, procedures, tooling, and/or automation.
9. Execute functional deliverables associated with PDP/TDP, Project Management, and Quality Systems.
10. Plan, organize, and conduct technical reviews.
11. Ensure proper documentation to meet quality systems requirements.
12. Review or coordinate vendor activities to support development.
13. Demonstrate strong knowledge of Lean methodologies and process improvement tools.
14. Apply process and equipment validation techniques, PFMEA's, and regulatory requirements.
15. Coordinate validation builds, testing, and compilation of validation results.
16. Commit to patient safety and product quality.
17. Understand and comply with quality system regulations.
Qualifications/Experience:
1. 5 years of engineering experience in a GMP environment.