Process Engineer II
Boston Scientific – Clonmel, County Tipperary, Ireland (Permanent)
We are seeking a Process Engineer II to join the Process Development Team. This role works cross‑functionally in the process development of complex technologies on new products and ensures efficient transfer of product 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.
* Maintains detailed documentation throughout all phases of development.
* Works as part of the Process Development group to aid design of new equipment for new products & manufacturing.
* Works closely with machine vendors to ensure that 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 and Quality Systems.
* Plans, organizes, and conducts all aspects of technical reviews.
* Ensures proper documentation is completed to meet quality systems requirements (e.g., BOMs, FMEAs, etc.).
* Reviews or coordinates vendor activities to support development.
* Demonstrates knowledge and application of Lean methodologies and process improvement tools in identifying and eliminating waste process steps and development of efficient, cost‑effective equipment and processes.
* Demonstrates knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), FMEA, 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.
Qualifications
* Honors/bachelor’s degree in engineering (qualification).
* 3+ years engineering experience in a GMP environment.
Requisition ID: 617429
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.
#J-18808-Ljbffr