REQ Solutions
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Base pay range
$55.00/hr - $58.00/hr Title: Design Quality/Design Assurance Engineer Location: Maple Grove, MN, 55311 Duration: 12+ Months Type: Hybrid Role Key Responsibilities
Core Team Leadership: Act as the voice of quality on the cross-functional product development team, ensuring design implementation aligns with strategic business objectives and quality standards. Design History File (DHF) Ownership: Lead the creation, maintenance, and audit-readiness of the DHF, ensuring all documentation meets internal and regulatory requirements. Risk Management: Own and execute the risk management process, including development of Hazard Analyses, Task Analyses, DFMEAs, and Software FMEAs as applicable. Verification & Validation (V&V): Lead planning, execution, and documentation of design verification and validation activities, including protocol development, test execution, and issue resolution. Global Collaboration: Work with international teams to align quality deliverables, share best practices, and ensure consistent execution across geographies. Regulatory Compliance: Ensure adherence to applicable standards (e.g., ISO 13485, ISO 1497, FDA QSR, EUMDR) and support regulatory submissions as needed. Mentorship & Guidance: Provide technical leadership and mentorship to global, cross-functional partners. Qualifications
Bachelor’s or master’s degree in engineering, Mathematics, Physics or related field. Minimum 5 years of experience in Design Quality Assurance or Product Development Engineering, preferably in medical device development. Strong knowledge of Design Controls, Risk Management, and Verification & Validation methodologies. Excellent communication and collaboration skills across global teams. Experience with ISO 10555, ISO 80369, ISO 7864 is a plus. Seniority level
Mid-Senior level Employment type
Contract Industries
Medical Equipment Manufacturing
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$55.00/hr - $58.00/hr Title: Design Quality/Design Assurance Engineer Location: Maple Grove, MN, 55311 Duration: 12+ Months Type: Hybrid Role Key Responsibilities
Core Team Leadership: Act as the voice of quality on the cross-functional product development team, ensuring design implementation aligns with strategic business objectives and quality standards. Design History File (DHF) Ownership: Lead the creation, maintenance, and audit-readiness of the DHF, ensuring all documentation meets internal and regulatory requirements. Risk Management: Own and execute the risk management process, including development of Hazard Analyses, Task Analyses, DFMEAs, and Software FMEAs as applicable. Verification & Validation (V&V): Lead planning, execution, and documentation of design verification and validation activities, including protocol development, test execution, and issue resolution. Global Collaboration: Work with international teams to align quality deliverables, share best practices, and ensure consistent execution across geographies. Regulatory Compliance: Ensure adherence to applicable standards (e.g., ISO 13485, ISO 1497, FDA QSR, EUMDR) and support regulatory submissions as needed. Mentorship & Guidance: Provide technical leadership and mentorship to global, cross-functional partners. Qualifications
Bachelor’s or master’s degree in engineering, Mathematics, Physics or related field. Minimum 5 years of experience in Design Quality Assurance or Product Development Engineering, preferably in medical device development. Strong knowledge of Design Controls, Risk Management, and Verification & Validation methodologies. Excellent communication and collaboration skills across global teams. Experience with ISO 10555, ISO 80369, ISO 7864 is a plus. Seniority level
Mid-Senior level Employment type
Contract Industries
Medical Equipment Manufacturing
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