R&D Engineering Manager – Medical Devices

Are you a well rounded engineer with experience developing medical devices and taking them through process development? We are searching for an engineer looking to move up into an R&D Engineering Manager position for a respected medical devices company. This company boasts a strong growth trajectory over the years with aggressive plans going forward.

The R&D Engineering Manager will lead a small engineering team responsible for the design, development, implementation, and control of new and improved manufacturing processes. The R&D Engineering Manager will provide daily support, as the “player coach” face of engineering. In this highly visible role, you will have regular contact with the CEO and key company opinion leaders, including sales and customers. It is a great opportunity for a motivated engineer to move into a management position.

Requirements for the R&D Engineering Manager:

• Bachelor’s Degree in engineering preferably mechanical or biomedical.
• 5+ years’ medical device experience with experience in R&D and process development.
• Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer experience, product/process failure mode and effects analysis (FMEA), and problem solving methodologies.
• Understanding of medical device design controls / quality systems and product development processes
• Experience with ISO 13485
• Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements.
• Excellent verbal/written communication skills
• Strong leadership and mentoring skills with the desire and ability to inspire and drive teams
• Ability to organize, record, and implement procedures
• Six Sigma training, certification preferred
• Experienced in CAD, preferably SolidWorks