Senior Design Assurance Engineer (Medical Device)

Job Description

Job Description

Job Title: Senior Design Assurance Engineer (Medical Device)
Location: Arden Hills, MN
Duration: 6/12+ Month Contract – Possible Extension

Need a Senior Level person—someone who is hands-on, a doer, not a manager.

Job Details:
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet client, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication regarding quality initiatives that support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support for new product development, operational tasks, or system/service support.

oDesign Matrices/Prints/Design Controls
• Previous design controls and verification experience
• Design History File Experience
• Previous experience working on a ISO standard gap project
• Prior understanding of ISO 14791 and risk management
• 10 years of experience working as a design assurance engineer