New Product Development Engineer
Our client, a global medical device company, is seeking a New Product Development Engineer to lead higher-level engineering efforts in designing and developing new medical devices, manufacturing processes, equipment, and systems.
Key Responsibilities:
* Support new product development by leading technical assessments of new product design inputs and collaborating with cross-functional teams to deliver high-quality solutions.
* 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.
* Provide direction or lead higher-level engineering efforts to design products, processes, equipment, tooling, and components using engineering principles 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.
* 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 and recommend 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.
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, SolidWorks or equivalent modeling system, statistical analysis, and computerized analysis (FEA) applications.
* Self-motivated 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.