Design Assurance Engineer

A medical device manufacturing client is looking to hire a Senior Design Assurance Engineer in Maple Grove. This person will be responsible for design of quality input and deliverables for new product development programs. This person will] support sustaining activities for investigational and commercial device manufacturing, such as changes, audits, and post-market surveillance ensuring a continuously accurate and compliant Design History File.

• Plan/Report, Hazards Analysis, FMEA/Risk Assessment per ISO 14971
• Test Method development and validation
• Draft, collaborate, and approve product development deliverables and engineering work orders
• Consult and provide guidance on biocompatibility testing per ISO 10993 or collaborate with outside Contract Research Organization
• Coordinate and execute, as necessary, testing in support of new product development
• Support the transfer of designs from R&D to manufacturing
• Create and maintain up-to-date product Design History Files (DHF)
• Advise project teams and lead by example in best-practices for Quality and Regulatory compliance
• Proactively identify redundancy and opportunities for efficiency in Quality System requirement
• Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are appropriately documented and executed with a lens towards design, risk, and regulatory compliance
• Receive, investigate, and document product complaints, interacting with customers as applicable
• Support audits as Subject Matter Expert for QMS processes and product DHFs
• Drive Product Lifecycle Management architecture and changes

• 5+ years of experience in medical device development
• 3+ years of experience in a Design Assurance or Quality Engineering
• Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.
• Understanding of ISO 14971 and application of risk management to product development and processes.
• Demonstrated use of quality tools and methodologies such as nonconformance, CAPAs, root cause analysis, etc.
• Familiarity with statistical software, such as Minitab

Salary of $100,000 - $130,000 + 15% Bonus