Design Quality Engineer
Design Quality/New Product Engineer
Our client is a large medical device manufacturer. They manufacturing a number of class 2 and 3 medical devices. They are in need of a design quality/new product engineer to come in and help with Tech File remediation of design related documents.
Duties/Responsibilities/Scope of Work
The consultant must have 5-10 years of medical device design/quality engineering experience. Ideally they will have dealt with mechanical device design. They will be working on lots of design engineering documentation as well as reviewing and creating drawings using CAD, specifically Pro-E. Having specific Pro-E experience is not required. They will be supporting Risk Management, DHF and DFMEA remediation as well as design verification and validation documents. This will be primarily around revisions on existing product lines.
· A minimum BS degree in a technical discipline with five plus years related experience as an engineer in the medical device industry.
· Strong background in design documentation including design verification and validation
· DHF review, DFMEA review and revision
- CAD experience (solidworks, Pro-E, CREO, etc). Review and creation