We are seeking a skilled New Product Development Engineer to join our global medical device team.
Role Overview
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.
* Support new product development by leading the technical assessment of new product design inputs, collaborating closely with the cross-functional team, delivering high-quality solutions to meet user needs.
* Translate multiple inputs from Regulatory, Quality, Marketing, Human Factors, etc., into product requirements, specifications, and detailed trace matrices.
* 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.
Key Responsibilities
• Provide appropriate direction or directly lead higher-level engineering efforts to design products, processes, equipment, tooling, and components 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.
• 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, and 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 SOPs, Work Instructions, and Validation Protocols & Reports.
Requirements
Bachelor of Science in Mechanical or Biomedical Engineering; Professional Engineer certification or advanced degree preferred. 6 or more years of relevant experience in the 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, Solid Works or equivalent modeling system, statistical analysis, and computerized analysis (FEA) applications.
* Self-motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals.