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At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
Advancing possibilities for a brighter tomorrow
We are seeking a Senior Process Engineer on a permanent basis to join our team at Boston Scientific Clonmel. This role will work cross-functionally to lead process development of complex technologies on new products and ensures efficient and effective transfer of product into production.
Purpose
Responsible for providing engineering support in the creation and the development of new medical device products (invasive and non-invasive), focused in additive manufacturing. 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. Mantains detailed documentation throughout all phases of development.
6. Works as part of the Process Development group to aid design of new equipment for new products & manufacturing.
7. Works closely with machine vendors to ensure that the equipment is designed, built & tested according to Boston Scientific specifications.
8. Experience with working with Laser Systems & Laser materials processing (Welding, Marking, Cutting, etc.) is an advantage.
9. Knowledge in CNC code or CAD/CAM would be beneficial.
10. Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
11. Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
12. Plans, organizes, and conducts all aspects of technical reviews.
13. Ensures proper documentation is completed to meet quality systems requirements (e.g., BOM’s, Routers, FMEA’s, etc.).
14. Reviews or coordinates vendor activities to support development.
15. Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools.
16. Demonstrates strong knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), PFMEA’s, and associated regulatory requirements.
17. Coordinates execution and documentation of validation builds, testing of validation units, and the compilation, analysis and reporting of the validation results.
18. Demonstrates a primary commitment to patient safety and product quality.
19. Understands and complies with all the regulations governing the quality systems.
20. Experience with catheter-based single-use devices is beneficial.
Qualifications/Experience:
1. Hons bachelor’s degree in engineering or relevant field.
2. 5+ years engineering experience in a GMP environment.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Choosing a career with Boston Scientific isn’t just business, it’s personal. If you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
To search and apply for open positions, visit: Boston Scientific Careers
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and 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. We are committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com.
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