Principal R&D Engineer (medical devices)

Global medical devices leader seeks a Principal R&D Engineer to lead exciting new cardiovascular implant research and development projects at the company's flagship site in Irvine, CA.

The Principal R&D Engineer will:

• Develop Class III cardiovascular implantable devices from concept through launch. These could include including catheter delivery systems, ICD, LVAD, stents, TAVR, heart valves or vascular grafts
• Manage product development process which will include concept development, defining and generating design requirements, prototyping, and leadership of preclinical studies and clinical testing
• Manage staff R&D engineers

Requirements:

• Bachelor's degree in engineering; preferably in mechanical engineering or biomedical engineering - advanced degree preferred
• 7+ years full life cycle experience in the development of cardiovascular implantable devices such as ICD, LVAD, TAVR, catheters, pacemakers, heart valves, stents and/or vascular grafts
• Experience with a variety of metals typically used for cardiac implantables and delivery devices. These could include stainless steels, nickel-titanium alloys, tantalum, cobalt-chromium alloys, and platinum chromium
• Experience with mechanical design of small parts commonly used in cardiac repair and intervention
• Experience developing and running design verification testing for long term viability of implantable devices
• Experience writing and delivering reports and technical summaries supporting clinical submissions as well as submissions to applicable regulatory agencies
• A track record of technical accomplishment in developing Class III cardiovascular implantable devices
• Strong communications skills; oral, written and electronic
• The ability to work independently or as a lead in a cross functional environment
• Strong technical knowledge of the cardiovascular implantable device industry landscape
• Experience with some of the following: product design, "hands on" prototyping, DFM - design for manufacturing, new process development, tech transfer from R&D to produciton
• Project management experience; PMP a plus
• Strong working knowledge of SolidWorks or other applicable product development CAD software

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