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
Send Resume to paramesh at surfsearch dot org
