The primary purpose of the Research and Development Engineer (Sustaining) at Cook Winston-Salem is to design, test and technically document the feasibility, construction and production process of new and/or changed medical products.
• Design and maintain Design History files
• Design product modifications and/or develop process improvements as needed to meet standards, or for the purpose of product quality improvement
• Design new product ideas as assigned by VP of Engineering
• Build and test new product prototypes
• Document the final product design
• Assist in writing design and specification documentation for FDA application
• Initiate and oversee the pre-production run of new products
• Plan the ongoing production of the product
• Consult with Production personnel for device changes/updates as necessary
• Maintain a design file for each new product and turn that file over at product completion for permanent records
• Call on vendors to assess raw materials
• Call on physicians to discuss product ideas or evaluations
• Attend various trade shows to source raw materials or to attend Company exhibitions
• Minimum 4 year degree in Engineering/Technology
• Ability to work independently and remain self-motivated
• Experience and understanding of the validation process
• Ability to travel 25% of the time
• Approximately 75% of the time is spent in a normal office environment requiring sitting and moving around the building, or in a "clean" environment Production setting requiring protective clothing and safety glasses
• Approximately 25% of the time is spent in travel to various hospitals, physicians’ offices and public places
Experience with Design Controls processes in the medical device/FDA regulated industry (i.e. build and maintain Design History Files - DFMEA) is preferred.
Equal Opportunity Employer
Qualified candidates must be legally authorized to be employed in the United States. COOK does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.