Medical Device Design Engineer

JOB TITLE: Medical Device Design Engineer

SUPERVISION RECEIVED: Reports to the VP of Engineering

SUPERVISION EXERCISED: None

TYPICAL PHYSICAL DEMANDS:

• Travel as required to attend surgical events, trainings and customer meetings
• The noise level in the work environment is usually moderate
• Attend surgical procedures to interact with surgeon and gather direct input for medical device design parameters and function
• The ability to listen to and understand information and ideas presented through spoken words and sentences
• Employee must occasionally lift or move up to 50 pounds
• The ability to concentrate on a task over a period of time without being distracted
• Specific vision abilities required include close vision, distance vision, color vision, depth perception, and the ability to adjust focus
• The ability to communicate information and ideas by speaking so others will understand
• 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

TYPICAL WORKING CONDITIONS: Office and machine shop environment

DESIGN ENGINEER JOB FUNCTIONS:

• Travel to surgical cases to gather input from surgeons.
• Work directly with top management, senior engineer, and surgeon customers to develop design input guidelines for new surgical implant systems.
• Responsible for completing design control documents, quality system documents and creating the DHF for FDA review through the 510(k) process.
• Design transfer and DMR maintenance.
• Participate in anatomic test labs with surgeons.
• 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.

DESIGN CONTROL ACTIVITIES & RESPONSIBILITIES:

• Comprehensive knowledge of Design History File, Design Transfer, and DMR maintenance
• Proficient in the Design Control process with knowledge of tracing DHF documents to product requirements including Design Input / Output / Verification / Validation