Design Quality Engineer

Design Quality Engineer

Location: Minnesota (Onsite)

Job Summary

We are looking for an experienced Design Quality Engineer to support our engineering and product development activities onsite in Minnesota. The ideal candidate will have strong experience working with design quality processes, risk management, and verification/validation activities, preferably within a regulated product development environment.

This person will work closely with R&D, engineering, quality, and regulatory teams to make sure product designs meet applicable quality and safety requirements throughout the development lifecycle.

Key Responsibilities

• Support design quality activities throughout the product development lifecycle.
• Develop, review, and maintain Design FMEAs (DFMEA) and related risk management documentation.
• Perform and support Hazard Analysis and identify potential product and process risks.
• Support overall Design Risk Management activities and ensure risks are properly identified, evaluated, mitigated, and documented.
• Review and support Design Outputs to ensure they meet design input and quality requirements.
• Develop and execute Design Verification plans and activities.
• Support Design Validation / TMV (Test Method Validation) activities, including test planning, execution, and documentation.
• Prepare, review, and maintain Risk Management Files and ensure appropriate traceability throughout the product lifecycle.
• Work with cross-functional engineering and quality teams to identify design risks and develop appropriate mitigation strategies.
• Review engineering and technical documentation for compliance with internal procedures and applicable quality requirements.
• Participate in design reviews and provide quality input related to product risks, verification, validation, and design controls.
• Assist with investigation and resolution of design-related quality issues.
• Ensure required documentation is completed accurately and maintained according to project and quality system requirements.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Biomedical Engineering, or a related technical field.
• Strong experience in Design Quality Engineering and product development.
• Hands-on experience with DFMEA, Hazard Analysis, Risk Management, and Risk Management Files .
• Experience with Design Verification and Design Validation activities.
• Experience with TMV / Test Method Validation is highly preferred.
• Strong understanding of Design Controls and design documentation.
• Experience reviewing and maintaining Design Outputs and technical documentation.
• Ability to work effectively with R&D, engineering, quality, regulatory, and cross-functional teams.
• Strong documentation, communication, and problem-solving skills.

Preferred Experience

• Experience working in a regulated industry, particularly medical devices, healthcare, or other highly regulated products .
• Familiarity with ISO 14971 , design control requirements, and risk management practices.
• Experience supporting new product development (NPD) and sustaining engineering projects.
• Experience with quality and risk management tools/software is a plus.

Work Arrangement