Participate in anatomic test labs with surgeons.Responsible for completing design control documents, quality system documents and creating the DHF for FDA review through the 510(k) process.Work directly with internal manufacturing team for prototype and development of implants and surgical instruments to support the rapid development of new ortho-spine implant systems.Work directly with top management, senior engineer, and surgeon customers to develop design input guidelines for new surgical implant systems.TYPICAL WORKING CONDITIONS: Office and machine shop environment Travel as required to attend surgical events, trainings and customer meetings.Attend surgical procedures to interact with surgeon and gather direct input for medical device design parameters and function.The ability to concentrate on a task over a period of time without being distracted.The ability to communicate information and ideas by speaking so others will understand.The ability to listen to and understand information and ideas presented through spoken words and sentences.The noise level in the work environment is usually moderate.Employee must occasionally lift or move up to 50 pounds. ![]() While performing the duties of this job, the employee is frequently required to stand, walk, sit, use hands to handle, manipulate, or feel objects, tools or controls, reach with hands and arms, talk and hear.Specific vision abilities required include close vision, distance vision, color vision, depth perception, and the ability to adjust focus. ![]() SUPERVISION RECEIVED: Reports to the VP of Engineering JOB TITLE: Medical Device Design Engineer
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