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# Design Assurance Engineer

- **Company:** Manpower
- **Location:** Minneapolis, MN, United States
- **Experience:** Expert
- **Salary:** $100,000.0 - $130,000.0
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Failure Mode Effects Analysis
- **Published:** July 30, 2026
- **Apply:** https://www.minneapoliscareersite.com/job.asp?id=3336263942&tx=TT4542THT&pt=1&aff=0B19D771-A501-4A5E-8338-2A822B784D54&utm_source=Job%20Feed&utm_medium=textkernel&utm_campaign=DE&utm_term=0B19D771-A501-4A5E-8338-2A822B784D54

## About the Role

* Bachelor's degree in Engineering or a related technical field.
 * Minimum of 5 years of experience in design assurance, quality engineering, or a related role within a regulated industry.
 * Strong knowledge of design control requirements and risk management principles.
 * Experience working within a Quality Management System (QMS).
 * Familiarity with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971 (or equivalent in other regulated industries).
 * Excellent analytical, problem-solving, and communication skills.
 * Ability to work effectively in cross-functional teams.

## Description

* Lead and support design assurance activities throughout the product lifecycle, from concept through commercialization and post-market.
 * Ensure compliance with applicable regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC standards as applicable).
 * Participate in design control processes, including design planning, inputs/outputs, verification, validation, and design transfer.
 * Facilitate and contribute to risk management activities, including hazard analysis, FMEA, and risk mitigation strategies.
 * Collaborate cross-functionally with R&D, Quality, Regulatory Affairs, Manufacturing, and suppliers to ensure design quality and compliance.
 * Review and approve design documentation to ensure completeness, accuracy, and regulatory alignment.
 * Support change control processes and assess the impact of design changes.
 * Contribute to internal and external audits, including regulatory inspections.
 * Drive continuous improvement initiatives related to product quality and development processes.


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