Purpose
Boston Scientific Clonmel is hiring a Senior Process Engineer to join its Process Development Team. 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.
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
Researches, develops, designs, and evaluates mechanical and electro‑mechanical materials, components, assemblies, processes and/or equipment.
Conducts feasibility studies to verify capability and functionality.
Develops new concepts from initial design to market release.
Write and submit intellectual property (patents).
Maintains detailed documentation throughout all phases of development.
Working as part of the Process Development group this person will aid design of new equipment for new products & manufacturing. This person will play a key role in the design phase of the equipment from initialisation to final handover.
Work closely with machine Vendors in order to ensure that the equipment is designed, built & tested according to Boston Scientific specifications and is properly handed over to manufacturing.
Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
Plans, organizes, and conducts all aspects of technical reviews.
Ensures proper documentation is completed to meet quality systems requirements (e.g., BOM’S, Routers, FMEA’S, etc.).
Reviews or coordinates vendor activities to support development.
Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
Demonstrates strong knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), PFMEA’S, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
Demonstrates a primary commitment to patient safety and product quality.
Understands and complies with all the regulations governing the quality systems.
Experience with low‑pressure dispense systems and injection moulding an advantage.
Qualifications/Experience
Level 8 Hons Bachelor Degree (or higher) in Engineering or relevant discipline.
5+ years engineering experience in a GMP environment.
Laser weld experience highly advantageous.
At Boston Scientific, we recognise 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. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is 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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