Diversity, Innovation, Caring and Global Collaboration are the core values of Boston Scientific, a leader in medical science for over 40 years. We're committed to solving the most pressing challenges in the health industry, united by a deep care for human life.
We're seeking a Senior Process Engineer on a permanent basis to join our team at Boston Scientific Clonmel. In this role, you'll lead process development of complex technologies on new products and ensure efficient transfer into production.
Purpose
As a Senior Process Engineer, you'll provide engineering support in creating and developing new medical device products, focusing on additive manufacturing. You'll work closely 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. Write and submit intellectual property (patents).
5. Maintain detailed documentation throughout all phases of development.
6. Collaborate with the Process Development group to design new equipment for new products and manufacturing.
7. Work with machine vendors to ensure equipment is designed, built, and tested according to Boston Scientific specifications.
8. Experience with laser systems and laser materials processing (welding, marking, cutting, etc.) is an advantage.
9. Knowledge of CNC code or CAD/CAM would be beneficial.
10. Apply technical knowledge to innovate, design, and develop processes, procedures, tooling, and/or automation.
11. Execute functional deliverables associated with PDP/TDP, Project Management, and Quality Systems.
12. Plan, organize, and conduct all aspects of technical reviews.
13. Ensure proper documentation is completed to meet quality systems requirements (BOM's, Routers, FMEA's, etc.).
14. Review or coordinate vendor activities to support development.
15. Demonstrate strong knowledge and application of Lean methodologies and process improvement tools.
16. Demonstrate strong knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), PFMEA's, and associated regulatory requirements.
17. Coordinate execution and documentation of validation builds, testing of validation units, and compilation, analysis, and reporting of validation results.
18. Demonstrate a primary commitment to patient safety and product quality.
19. Understand and comply with all regulations governing quality systems.
20. Experience with catheter-based single-use devices is beneficial.
Qualifications/Experience
1. Honours bachelor's degree in engineering or relevant field.
2. 5+ years engineering experience in a GMP environment.
At Boston Scientific, we recognize the importance of nurturing a diverse and inclusive workplace. This helps us innovate and advance science for life, ultimately improving patient health. We stand for inclusion, equality, and opportunity for all. Boston Scientific is proud to be an equal opportunity and affirmative action employer.