New Product Development Engineer
We are seeking a skilled New Product Development Engineer to join our team at {company}. The successful candidate will lead higher-level engineering efforts in designing and developing new medical devices, manufacturing processes, equipment, and systems.
Key Responsibilities:
* Lead technical assessments of new product design inputs and collaborate with cross-functional teams to deliver high-quality solutions that meet user needs.
* Translate regulatory, quality, marketing, human factors, and other inputs into product requirements, specifications, and detailed trace matrices.
* Interface with marketing, healthcare professionals, customers, and suppliers to identify product opportunities, develop solutions, and complete projects leading up to commercialization of new products or modifications to existing ones.
* Direct or lead higher-level engineering efforts to design products, processes, equipment, tooling, and components using engineering principles on Computer-Aided Design (CAD) systems 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 Engineering Development projects, including Problem-Solving projects to resolve issues in Manufacturing or Product Performance, and provide uniform solutions for international manufacturing operations.
* Champion Continuous Improvement of manufacturing processes and equipment through Lean Manufacturing and statistical data analysis techniques.
* 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 or equivalent; 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, SolidWorks or equivalent modeling system, statistical analysis, and computerized analysis applications.
* Self-motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals.
* Excellent multi-tasking, analytical, communication, and prioritization skills.
* Able to work independently with minimal supervision as well as in a team environment.
* Excellent communicator with the ability to run meetings and workshops.
* Able to travel domestically and internationally.