> Markdown version of [/jobs/ext/1716601-senior-design-assurance-engineer](https://www.wearedevelopers.com/jobs/ext/1716601-senior-design-assurance-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). --- # Senior Design Assurance Engineer - **Company:** Phillips, Phillip - **Location:** Plymouth, MN, United States - **Experience:** Expert - **Salary:** $91,350.0 - $146,160.0 - **Contract:** Permanent contract - **Skills:** Issue Tracking Systems, Verification and Validation (Software) - **Published:** July 31, 2026 - **Apply:** https://www.juju.com/job/00000000gkonte ## About the Role + You have a minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971) and strong Understanding of all aspects of the QMS related to Design/Process Controls. + You have strong understanding of Medical Device QSR regulations/standards including ISO 13485, ISO 14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR. + You're able to analyze quality data and draw conclusions regarding trending, KPI's etc. + You have extensive experience supporting the creation and review of all medical device documentation including- Component qualification, Design Verification Test/regression plans, test protocols/reports, process validation, issue tracking/resolution and auditing Design History Files (DHF). + You have the proven ability to cultivate and maintain strong relationships with team members and internal/external stakeholders. + You have a minimum of a bachelor's degree in Quality, Engineering (Mechanical, Chemical, Biomedical) or a related Scientific discipline **(required).** ASQ certifications (desired). ## Description The Senior Design Assurance Engineer will play a critical role in support of the design controls process, with a focus on Sustaining and New product development (NPI) of Philips' Image Guided Therapy Devices (IGTD). Your role: + Ensures Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, and updating risk documents, component qualification, statistical analysis of data, design verification and process validation planning as well as quality system compliance. + Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements. + Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will ensure specific quality levels. + Works with cross functional teams to complete component qualification activities, plan/conduct design verification (DVT) and process validation activities. + Participates in the development/results analysis of verification and validation (V&V) plans and test protocols to qualify and validate new product designs and processes. ## Related Videos - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Recruiting in 2025: Will AI Help or Take Over?](https://www.wearedevelopers.com/videos/1301-recruiting-in-2025-will-ai-help-or-take-over) - [Times of (climate) crisis - How and why sustainable software is a must!](https://www.wearedevelopers.com/videos/988-times-of-climate-crisis-how-and-why-sustainable-software-is-a-must) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [7 tips for releasing on a Friday afternoon: YouTrack to the rescue](https://www.wearedevelopers.com/videos/204-7-tips-for-releasing-on-a-friday-afternoon-youtrack-to-the-rescue) - [Kettle and Pot or Peas in a Pod? A Debate on Open-Source and Proprietary Software](https://www.wearedevelopers.com/videos/1585-kettle-and-pot-or-peas-in-a-pod-a-debate-on-open-source-and-proprietary-software) ## Related Articles - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [How Developers Can Focus on Maintaining Satisfaction With Accessibility](https://www.wearedevelopers.com/magazine/109-how-developers-can-focus-on-maintaining-satisfaction-with-accessibility) - [Events like RSAC Get You CISOs. Developers Decide What Actually Gets Deployed.](https://www.wearedevelopers.com/magazine/693-events-like-rsac-get-you-cisos-developers-decide-what-actually-gets-deployed) - [Why developer experience matters](https://www.wearedevelopers.com/magazine/514-why-developer-experience-matters) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)