> Markdown version of [/jobs/ext/2572765-design-quality-engineer](https://www.wearedevelopers.com/jobs/ext/2572765-design-quality-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Design Quality Engineer - **Company:** Amazon.com, Inc. - **Location:** Bothell, WA, United States - **Experience:** Expert - **Salary:** $76,960.0 - $85,280.0 - **Contract:** Permanent contract - **Skills:** Adobe InDesign, Failure Mode Effects Analysis, Requirements Traceability, GXP - **Published:** August 30, 2026 - **Apply:** https://www.careerjet.com/jobad/us26015d1724d5f067f263a24ce00576b0 ## About the Role * Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or an equivalent/relevant discipline. * 5+ years of experience in FDA-regulated medical device environments, with a strong focus on Design Quality, Design Assurance, or Design Controls. * Demonstrated experience with risk management, change management, and design/manufacturing transfer. ## Description We are seeking an experienced Design Quality Engineer (DQE) to support medical device product design and development activities. This position partners closely with R&D, Regulatory, Manufacturing, Quality, and Supplier teams to ensure quality and regulatory requirements are incorporated throughout the product lifecycle. Key Responsibilities * Ensure compliance with Design Control requirements in accordance with 21 CFR Part 820 and ISO 13485. * Participate in design planning, cross-functional design reviews, and Design Verification & Validation (V&V) activities. * Review and approve design inputs, design outputs, specifications, verification/validation documentation, and other technical records. * Support creation and maintenance of traceability documentation and DHF, DMR, and DHR records. * Ensure Design V&V activities adequately demonstrate that established requirements have been met. * Review and approve Engineering Change Requests/Orders (ECR/ECO) and ensure design changes follow established change-control processes. * Evaluate critical design inputs related to usability, reliability, performance, manufacturability, and safety. * Support design transfer to manufacturing and ensure appropriate manufacturing/process readiness. * Build effective relationships with internal and external stakeholders and provide Design Quality guidance to cross-functional teams. Risk Management * Guide risk-management activities throughout the medical device product lifecycle. * Facilitate DFMEA, PFMEA, hazard analysis, and risk assessments. * Ensure identified risk controls are appropriately implemented, verified, traceable, and documented. * Support risk-management activities in accordance with ISO 14971. QMS / Compliance Support * Support internal and external quality audits and regulatory inspections. * Maintain accurate and inspection-ready quality documentation. * Support CAPA, root-cause analysis, corrective actions, and effectiveness activities. * Contribute to development, implementation, and revision of Quality Management System processes. Required Skills * Strong hands-on experience with Medical Device Design Controls and Design Assurance. * Design Verification & Validation (V&V). * Design Inputs/Outputs and Requirements Traceability. * DHF, DMR, and DHR documentation. * Design Reviews and action-item closure. * DFMEA, PFMEA, Hazard Analysis, and ISO 14971 Risk Management. * ECR/ECO and Change Control. * Design Transfer and Manufacturing Transfer. * CAPA and Root Cause Analysis. * Audit and inspection readiness. * Strong cross-functional experience working with R&D, Regulatory, Manufacturing, Quality, and Supplier teams. Regulatory Knowledge * FDA 21 CFR Part 820 * ISO 13485 * ISO 14971 * EU Medical Device Regulation (EU MDR) * European Medical Device Directive * Canadian Medical Device Regulations, Last Mile Delivery & Technology is responsible for envisioning and developing forward-looking initiatives to improve the efficiency, speed, quality, and safety of the delivery expe… + 24 days ago, Job Description: The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requ… + 1 month ago + ## Related Videos - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Design as an algorithm, not as a feature](https://www.wearedevelopers.com/videos/471-design-as-an-algorithm-not-as-a-feature) - [Let’s Talk Quality!](https://www.wearedevelopers.com/videos/100012-let-s-talk-quality) - [Your Tests Are Lying to You: Let AI Expose What You Missed](https://www.wearedevelopers.com/videos/100007-your-tests-are-lying-to-you-let-ai-expose-what-you-missed) - [What If We Designed Employee Experience Like a Customer Journey?](https://www.wearedevelopers.com/videos/1824-what-if-we-designed-employee-experience-like-a-customer-journey) ## Related Articles - [Why developer experience matters](https://www.wearedevelopers.com/magazine/514-why-developer-experience-matters) - [Are design and development really just the same thing?](https://www.wearedevelopers.com/magazine/520-are-design-and-development-really-just-the-same-thing) - [Dev Digest 162: AI careers, MCP, AWS best practices & floppy sweaters](https://www.wearedevelopers.com/magazine/571-dev-digest-162-ai-careers-mcp-aws-best-practices-floppy-sweaters) - [How Developers Can Focus on Maintaining Satisfaction With Accessibility](https://www.wearedevelopers.com/magazine/109-how-developers-can-focus-on-maintaining-satisfaction-with-accessibility) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development)