New Product Development Engineer
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:
* 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.
* 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.
* 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, 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.
* Adhere to and ensure compliance with the company's 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 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, SolidWorks 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.
* The ideal candidate will display excellent multi-tasking, analytical, communication, and prioritization skills.
* Ability to work independently with minimal supervision as well as in a team environment.
* Be an excellent communicator with the ability to run meetings and workshops.
* Able to travel domestically and internationally.