Design Assurance Engineer Jobs

Currently seeking a Development Quality Engineer for a global, premiere healthcare leader with a portfolio of life-changing technologies and products in diagnostics, medical devices, nutritionals and branded generic medicines.

This is an Onsite/Hybrid position Plymouth, MN – NOT a Remote opportunity.

• Generate PDP design verification test plans/reports for product/system requirements
• Ensure compliance with regulatory standards and maintain DHF content integrity
• Implement effective process control systems for product development and manufacturing
• Lead or participate in quality-related teams and decisions. Ensure on-time completion of design control deliverables
• Conduct or support Risk Management activities throughout the product development lifecycle
• Complete labeling verification activities and reports
• Assist in the development and execution of streamlined business systems to address quality issues
• Support the timely execution of Quality Plans for product development and design change projects
• Collaborate with design engineering for requirements, verification, and validation activities
• Support company initiatives and quality management systems (QMS) compliance

The ideal candidate will have a Degree in Engineering discipline coupled with experience in Process Validation, including IQ/OQ/PQ and Test Method Validation (TMV). Familiarity with design/failure investigations (CAPAs, NCMRs) helpful.

The role involves leading and supporting quality disciplines, participating in product development processes, and ensuring compliance with regulatory standards.

Additionally, the candidate will be responsible for risk management activities, document control, and implementing effective process control systems.

Familiarity with regulated industries (medical, aerospace, etc.) strongly preferred. Knowledge of systems such as EPIQ & Windchill PLM is helpful, but not required.