Purpose
Boston Scientific Clonmel is hiring a Process Engineer II (P2) to join our Process Development Team. The role works cross functionally in the process development of complex technologies on new products and ensures efficient and effective transfer of the product into production.
Responsibilities
Research, develop, design, and evaluate mechanical and electro mechanical materials, components, assemblies, processes and/or equipment.
Conduct feasibility studies to verify capability and functionality.
Develop new concepts from initial design to market release.
Maintain detailed documentation throughout all phases of development.
Work as part of the Process Development group, aiding the design of new equipment for new products and manufacturing.
Work closely with machine vendors to ensure equipment is designed, built, and tested according to Boston Scientific specifications and properly handed over to manufacturing.
Apply technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
Execute the functional deliverables associated with the PDP/TDP and Quality Systems.
Plan, organize, and conduct all aspects of technical reviews.
Ensure proper documentation is completed to meet quality systems requirements (e.g., BOMs, FMEAs, etc.).
Review or coordinate vendor activities to support development.
Demonstrate knowledge and application of Lean methodologies and process improvement tools to eliminate waste and develop efficient, cost effective equipment and processes.
Demonstrate knowledge and application of process and equipment validation techniques (IQ, OQ, PQ), FMEA, and associated regulatory requirements and apply this knowledge in the efficient & timely validation of equipment and processes.
Coordinate execution and documentation of validation builds, coordinate testing of validation units, and compile, analyze and report validation results.
Demonstrate a primary commitment to patient safety and product quality.
Understand and comply with all the regulations governing the quality systems.
Qualifications & Experience
Level 8 Hons Bachelor Degree (or higher) in Engineering or a relevant discipline.
3+ years engineering experience in a GMP environment.
Experience with laser welding highly advantageous.
EEO Statement
Boston Scientific is an equal opportunity and affirmative action employer. We are committed to providing reasonable accommodations for applicants and employees with a disability. If you require a reasonable accommodation during the recruitment process, please email .
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