Global medical devices leader is rolling out new Class II and Class III products and is seeking R&D Engineers to lead early stage product development of cardiovascular and infusion delivery systems. We are searching for engineers with "hands on" experience developing Class II electromechanical and Class III implantable medical devices.
Our clients seek engineers who are career-driven, have strong analytical and technical skills and a depth of experience in front end design. Our companies offer excellent career growth potential, and excellent benefits. We have many opportunities - all with top medical device companies seeking cutting edge engineering talent in research and development.
typical roles and responsibilities for R&D Design Engineer
- Develop complex cardiovascular delivery system devices or electromechanical infusion pumps which will include developing design requirements, generating design concepts, "hands on" prototyping and design evaluation
- Following applicable regulatory standards, design and test minimally-invasive catheter-based delivery systems or electromechanical infusion pumps accordance with specifications, medical guidance, and regulatory safety standards
- Write test protocols, reports and support documentation for design verification
Requirements for the R&D Design Engineer
- Bachelor's degree in engineering, preferably mechanical engineering; advanced degree preferred
- 6+ years (senior level) and 8+ years (principal level) progressive experience in Class II or Class III device design
- 5+ years’ experience in cardiac or peripheral catheter design or infusion pumps. This includes early stage and prototyping
- A track record of accomplishment in design and testing of Class II or Class III devices
- Project ownership of significant size and scope
- The ability to solve technical problems, implementing practical solutions based on device requirements and project timelines
- Excellent communications skills; oral, written and electronic
- Excellent statistical and analytical skills
- Demonstrated ability to design for manufacturability and implementing quality standards
- Experience working on DFMEA and PFMEA activities for new medical device products to improve design and process performances
- Experienced with Geometric Dimensioning and Tolerancing, Design Control, Design and Process Validations, Gauge R&R, Test Method validations, pilot manufacturing for clinical builds, design transfer for commercial manufacturing
- Experience working with Design History files from prototype to market release for medical devices.
- Experience optimizing processes, developing and implementing test procedures, forming process parameters, test methods and standard operating procedures, capacity and profitability for medical device manufacturing
Salary range for R&D Design Engineer