Senior R&D Engineer-New Product Development

Our client, a global medical device company, is currently seeking a New Product Development Engineer for their team. The New Product Development Engineer will lead higher-level engineering efforts to design and develop new medical devices, manufacturing processes, equipment, and systems by defining specifications, materials, and manufacturing procedures.

Role/Responsibilities:

1. Support new product development by leading the technical assessment of new product design inputs, collaborating closely and effectively with the cross-functional team, delivering high quality, original solutions to meet user needs.
2. Translate multiple inputs from Regulatory, Quality, Marketing, Human Factors, etc., into product requirements, specifications, and detailed trace matrices.
3. Interface with Marketing, Health Care Professionals, Customers, and suppliers as necessary to identify product opportunities, develop product solutions, solve problems, and complete projects leading up to commercialization of new and/or modifications to existing products.
4. Provide appropriate direction or directly lead higher-level engineering efforts to design products, processes, equipment, tooling, and components by using engineering principles on a Computer Aided Design (CAD) system and evaluating them using analysis techniques such as Finite Element Analysis (FEA).
5. Perform product testing, create models and prototypes to prove out new designs and changes to existing designs.
6. Lead higher-level Engineering Development projects as assigned, including Problem-Solving projects to resolve issues in Manufacturing or Product Performance. Provide uniform solutions for international manufacturing operations.
7. Champion Continuous Improvement of manufacturing processes and equipment through the use of Lean Manufacturing and statistical data analysis techniques such as TMV, Gage Studies, Process Capability Studies, DOE, and SPC.
8. Lead or participate in project, design, and technical reviews.
9. Interview, recommend, and assist in the selection of department personnel including engineers and summer interns.
10. Troubleshoot and coordinate improvements to existing products, manufacturing processes, and machine test equipment.
11. Support regulatory submissions and clinical trials as required.
12. Ensure projects are developed and documented in compliance with the Quality Management System.
13. Develop, approve, and revise Quality System Documents, including SOPs, Work Instructions, and Validation Protocols & Reports.
14. Adhere to and ensure compliance with the company's Code of Ethics, all Company policies, QMS procedures, and housekeeping standards.

Skills / Experience:

1. Bachelor of Science in Mechanical or Biomedical Engineering, Professional Engineer certification or advanced degree preferred; other technical disciplines considered.
2. 6 or more years of relevant experience in the engineering field related to manufacturing.
3. Strong analytical, technical, and problem-solving skills.
4. Hands-on experience preferred.
5. Effective verbal and written communication skills.
6. Team player with good interpersonal skills.
7. Proficient in Microsoft Office Suite, SolidWorks or equivalent modeling system, statistical analysis, and computerized analysis (FEA) applications.
8. Self-motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals.
9. The ideal candidate will display excellent multi-tasking, analytical, communication, and prioritization skills.
10. Ability to work independently with minimal supervision as well as in a team environment.
11. Be an excellent communicator with the ability to run meetings and workshops.
12. Able to travel domestically and internationally.

For further information please contact James Cassidy at james.cassidy@lifescience.ie or call in confidence at 0860204322.

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