clinical challenges, as well as engineering challenges as they relate to product and manufacturing. 2. Design Development... regulations/standards for medical product manufacturing and development: 21 CFR 820 (Quality System Regulation), 21 CFR 803...
This position is responsible for investigating, leading, planning, developing and implementing the more complex product design...) impact of design changes. 5. Lead and execute product design change projects from evaluation through validation. 6. Develop...
of the productdevelopment process. The position is also responsible for testing support of competitor product evaluations... for marketing information. Assisting in preparing the lab for simulated clinical evaluations and new product pilot lines...
) and will work collaboratively on new productdevelopment and sustaining engineering projects and activities. These assignments may... include test method development, new product concept testing, formal design verification testing, stability testing...
to appropriate stakeholders Provide engineering input in the design, fabrication, development, installation, validation... preferred. Experience with equipment and process validations, including development of protocols and execution of protocols...
Co-op position is specifically accountable for the product design, development, testing, and/or technical problem solving... could be to support productdevelopment prototype evaluations, or could be submitted to the FDA to support new product clearance or claims...