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.

What You’ll Do

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

Required Skills

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

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