Description

Job Summary:

The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.

 

Essential Functions:

+ Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables

+ Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & resolution activities

+ Lead Risk Management activities from product Concept through Commercialization

+ Support design...