Product Development engineer, San Antonio, TX
This is for a young fast growing organization that is developing novel devices in the orthopedic sector.
I am conducting a search for a product development engineer who has experience developing implants and instruments from concept to launch. Candidates should have at least 3 to 5 years of product development experience in the medical device industry.
This position will be responsible for the developing orthopedic implants and related instrumentation. Responsibilities will include: project management and planning, interfacing and coordinating project team activities, interfacing with surgeons and others end users to establish user requirements, developing prototypes, coordinating cadaver implant trials, developing and maintaining design history files, ensuring appropriate design control and documentation, developing product design schedules and providing documentation to support regulatory approvals.
Requirements:
-3 to 5 years Experience developing orthopedic, spine, CMF (prior extremity experience a very strong plus)
-Prior experience working with materials such as: Nitinol, a nickel-titanium alloy, Stainless steel
-Must have strong CAD software and designing skills (SolidWorks a plus)
-Proven knowledge of GMP, ISO and quality system practices
-Candidates must be able to interact and communicate with surgeons