Job Title: 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:
1. Support new product development by leading technical assessments of new product design inputs and collaborating with cross-functional teams.
2. Translate regulatory, quality, marketing, human factors, and other inputs into product requirements, specifications, and detailed trace matrices.
3. Interface with marketing, healthcare professionals, customers, and suppliers to identify product opportunities, develop solutions, and complete projects.
4. 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).
5. Perform product testing, create models, and prototypes to prove out new designs and changes to existing designs.
6. Lead higher-level Engineering Development projects, including problem-solving projects to resolve issues in manufacturing or product performance.
7. Champion Continuous Improvement of manufacturing processes and equipment through the use of Lean Manufacturing and statistical data analysis techniques.
8. Lead or participate in project, design, and technical reviews.
9. Interview, recommend, and assist in the selection of department personnel.
10. Troubleshoot and coordinate improvements to existing products, manufacturing processes, and machine test equipment.
11. Support regulatory submissions and clinical trials as required.
12. Ensure projects are developed and documented in compliance with the Quality Management System.
13. Develop, approve, and revise Quality System Documents, including SOPs, Work Instructions, and Validation Protocols & Reports.
14. Adhere to and ensure compliance with the company's Code of Ethics, all Company policies, QMS procedures, and housekeeping standards.
Requirements:
1. Bachelor of Science in Mechanical or Biomedical Engineering, Professional Engineer certification or advanced degree preferred.
2. 6 or more years of relevant experience in the engineering field related to manufacturing.
3. Strong analytical, technical, and problem-solving skills.
4. Hands-on experience preferred.
5. Effective verbal and written communication skills.
6. Team player with good interpersonal skills.
7. Proficient in Microsoft Office Suite, SolidWorks or equivalent modeling system, statistical analysis, and computerized analysis (FEA) applications.
8. Self-motivated, high energy, positive attitude individual with the initiative and drive for timely completion of goals.
9. Excellent multi-tasking, analytical, communication, and prioritization skills.
10. Ability to work independently with minimal supervision as well as in a team environment.
11. Excellent communicator with the ability to run meetings and workshops.
12. Able to travel domestically and internationally.