Boston Scientific Process Eng - P4 

Ireland 

101600186

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.
• Strong knowledge on Overmoulding processes & Technologies, including Core assembly and Overmoulded Skins
• Experience with working with Laser Systems & Laser materials processing (Welding, Marking, Cutting, etc) an advantage.
• Knowledge in CNC code or CAD\CAM would be beneficial.
• 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), PRA’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.

Qualifications/Experience:

• Hons BSc degree in engineering or relevant discipline
• 5+ yrs engineering experience in a GMP environment

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.