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
- Design Controls (plan, inputs/outputs, verification, design review, etc..) per 21 CFR820.30
- 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.
- Development project team member on complex medical device development programs, including systems
- 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
