Design Assurance Engineer
REQ SolutionsMaple Grove, MN, United Statesjob_description.job_card.variable_hours_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionBachelor’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. Proven experience delivering successful new product development product quality deliverables in a regulated environment. 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
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 :
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Design Assurance Engineer • Maple Grove, MN, United States
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