About the job
Nextern is actively seeking a talented Senior Design Assurance Engineer to join our innovative team in Maple Grove, Minnesota. This exciting opportunity offers competitive compensation and a comprehensive benefits package that supports your professional growth and well-being.
As a Senior Design Assurance Engineer, you will play a critical role in ensuring the quality and compliance of our new product development initiatives throughout the entire product lifecycle. You will also support ongoing activities for investigational and commercial device manufacturing, including audits and post-market surveillance, to maintain an accurate and compliant Design History File. Your expertise in quality systems and regulatory standards will be essential as you interact with both internal teams and Nextern customers to drive continuous improvement.
Key Responsibilities:
- Act as a core team member for product development projects, focusing on key deliverables such as:
- Design Controls (planning, inputs/outputs, verification, design reviews, etc.) in accordance with 21 CFR 820.30
- Risk Management (Planning/Reporting, Hazard Analysis, FMEA/Risk Assessment) in line with ISO 14971
- Equipment and Material Qualification
- Development and validation of Test Methods
- Collaborate on and approve engineering deliverables and work orders
- Provide expertise on biocompatibility testing per ISO 10993, or coordinate with external Contract Research Organizations
- Plan and conduct testing in support of new product development, including Design Verification and Performance Validation
- Facilitate the transition of designs from R&D to manufacturing
- Ensure the maintenance of up-to-date product Design History Files (DHF)
- Guide project teams in best practices for Quality and Regulatory compliance
- Identify opportunities for efficiency and redundancy reduction within Quality System requirements
- Review and approve changes, ensuring documentation of impacts and actions taken
- Investigate and document product complaints, interacting with customers as needed
- Serve as a Subject Matter Expert (SME) during audits for QMS processes and product DHFs
- Lead changes in Product Lifecycle Management (PLM) as required

