Senior R&D Process Engineer

Senior R&D Process Engineer
Responsible for providing mechanical engineering support in the creation and the development of new medical device products (invasive and non-invasive). Interfaces with Design, Quality and Manufacturing organizations to integrate new products, equipment sets or processes into production.

Responsibilities:

1. Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
2. Conducts feasibility studies to verify capability and functionality.
3. Develops new concepts from initial design to market release.
4. Writes and submits intellectual property (patents).
5. Maintains detailed documentation throughout all phases of development.
6. Working as part of the Process Development group, this person will aid in the design of new equipment for new products & manufacturing, playing a key role in the design phase from initialization to final handover.
7. Works closely with machine vendors to ensure that the equipment is designed, built & tested according to specifications and is properly handed over to manufacturing.
8. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
9. Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
10. Plans, organizes, and conducts all aspects of technical reviews.
11. Ensures proper documentation is completed to meet quality systems requirements (e.g., BOM's, Routers, FMEA's, etc.).
12. Reviews or coordinates vendor activities to support development.
13. Demonstrates strong knowledge and application of Lean methodologies and process improvement tools to identify and eliminate "waste" process steps and develop efficient, cost-effective equipment and processes.
14. Demonstrates strong knowledge and application of process and equipment validation techniques (IQ, OQ, PQ), PFMEA's, and associated regulatory requirements, applying this knowledge in the efficient & timely validation of equipment and processes.
15. Coordinates execution and documentation of validation builds, testing of validation units, and the compilation, analysis, and reporting of the validation results.
16. Demonstrates a primary commitment to patient safety and product quality.
17. Understands and complies with all regulations governing the quality systems.
18. Experience with low-pressure dispense systems and injection moulding is an advantage.

Qualifications/Experience:

1. 5 years of engineering experience in a GMP environment.