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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