Our client a global medical device company is currently seeking a New product Development Engineer their team. The New Product Development Engineer will lead higher level engineering efforts to design & develop new medical devices, manufacturing processes, equipment and systems by defining specifications, materials and manufacturing procedures
• 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.
• Translating multiple inputs from Regulatory, Quality, Marketing, Human Factors etc., into product requirements, specifications, and detailed trace matrices.
• Interface with Marketing, Health Care Professional’s, 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.
• 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).
• Perform product testing, create models and prototypes to prove out new designs and changes to existing designs.
• 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.
• 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.
• Lead or participate in project, design and technical reviews.
• Interview, recommend, and assist in the selection of department personnel including engineers and summer interns.
• Troubleshoot and coordinate improvements to existing products, manufacturing processes, machine test equipment.
• Support regulatory submissions and clinical trials as required.
• Ensure projects are developed and documented in compliance with the Quality Management System.
• Develop, approve, and revise Quality System Documents, including SOP’s, Work Instructions and Validation Protocols & Reports.
• Adhere to and ensure the compliance of companies Code of Ethics, all Company policies, QMS procedures and housekeeping standards.
Skills / Experience:
• Bachelor of Science in Mechanical or Biomedical Engineering, Professional Engineer certification or advanced degree preferred; other technical disciplines considered.
• 6 or more years of relevant experience in engineering field related to manufacturing.
• Strong analytical, technical and problem-solving skills
• Hands-on experience preferred.
• Effective verbal and written communication skills.
• Team player with good interpersonal skills.
• Proficient in Microsoft Office Suite, SolidWorks or equivalent modeling system, statistical analysis and computerized analysis (FEA) applications. Key Relationships / Interfaces:
• Self-motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals.
• The ideal candidate will display excellent multi-tasking, analytical, communication and prioritisation skills.
• Ability to work independently with minimal supervision as well as in a team environment.
• Be an excellent communicator with ability to run meetings and workshops
• Able to travel domestically and internationally.
For further information please contact James Cassidy firstname.lastname@example.org or call in confidence 0860204322