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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Software Design Quality Engineer - **Company:** Philips North America - **Location:** Bedford, MA, United States - **Experience:** Expert - **Salary:** $102,480.0 - $163,968.0 - **Contract:** Permanent contract - **Skills:** Testing (Software), Agile Methodology, C Sharp (Programming Language), C++ (Programming Language), Software Quality, Object-Oriented Software Development, Software Product Management, Systems Development Life Cycle, Software Engineering, Test Scripts, Information Technology, Software Performance - **Published:** August 1, 2026 - **Apply:** https://www.dice.com/job-detail/f8a48e9d-a4b5-4708-8ca6-869f0be3cec5 ## About the Role * You have a minimum of 5+ years' experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), SDLC and strong Understanding of all aspects of the QMS related to Software Design Controls. * You have proven experience in Root Cause Analysis, Software V&V, identifying/ supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Quality (DfQ), Agile, and SAFe. * Strong experience with complex medical systems containing software, hardware and disposables. * You're able to share knowledge, insights regarding software quality standards, and regulatory requirements. * You have excellent written and verbal communication skills, with the ability to communicate and present to all levels of management. * Ability to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements. * You have a minimum of a Bachelor's Degree (Required), in Quality, Computer Science/Engineering or similar disciplines. ISTQB certification desired. * You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an ON-SITE role. ## Description The Software Design Quality Engineer is responsible for developing, maintaining, and managing comprehensive software quality documentation, ensuring their accuracy and regulatory compliance throughout the software lifecycle. Your role: * Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies. * Lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation including- Software design/verification, Risk management, Systems validation, Traceability and Cyber security risk management. * Track and risk assess software Anomalies for pre- and post-market medical device software. * Conducts detailed root cause analyses for software quality issues and validating key design inputs like usability, reliability, and performance. * Assess products and systems to identify defects, abnormalities and design flaws by authoring and executing software test protocols and generating test reports. * Implements software quality plans and risk management activities, utilizes post-market analytics to monitor software performance, and initiates corrective actions as needed. * Ensure compliance across the product software lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access. * Drive regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards. ## Related Videos - [Let's Talk Quality! - Lilia Gargouri](https://www.wearedevelopers.com/videos/1815-let-s-talk-quality-lilia-gargouri) - [ShapeShift: Reinventing Agile for a B2B SaaS Scale-Up](https://www.wearedevelopers.com/videos/1655-shapeshift-reinventing-agile-for-a-b2b-saas-scale-up) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Are Classical Automation Frameworks Dead? How AI Agents Are Transforming QA](https://www.wearedevelopers.com/videos/100243-are-classical-automation-frameworks-dead-how-ai-agents-are-transforming-qa) - [Let’s Talk Quality!](https://www.wearedevelopers.com/videos/100012-let-s-talk-quality) - [The Affordances of Quality](https://www.wearedevelopers.com/videos/1134-the-affordances-of-quality) ## Related Articles - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Is Software Engineering Hard?](https://www.wearedevelopers.com/magazine/448-is-software-engineering-hard) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)