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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior System Design Quality Engineer - **Company:** Boston, Inc. - **Location:** Maple Grove, MN, United States - **Experience:** Expert - **Salary:** $85,000.0 - $161,500.0 - **Contract:** Permanent contract - **Skills:** Failure Mode Effects Analysis, Software Product Management, Systems Development Life Cycle, Software Engineering - **Published:** July 2, 2026 - **Apply:** https://jobs.localjobnetwork.com/apply/add/87616641/1 ## About the Role * Bachelor's degree in engineering or science discipline, or equivalent. * Minimum of 5 years experience in design assurance, quality, or related medical device or regulated industry experience * ISO 9001, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62304, CFRs, and Quality System Regulations understanding & demonstrated use * Strong communication skills (verbal & written) and presentation skills * Problem solver, capable of facilitating the problem-solving process & driving issues to closure * Excellent organizational and planning skills; drives for results * Adaptable and effective collaborator in a team environment and in self-directed work * Ability to work in a highly matrixed and geographically diverse business environment as the product expands Globally. * Demonstrated use of Quality tools/methodologies Preferred Qualifications: * Focus on detailed work with emphasis on accuracy and completeness * Ability to collaborate and work on a highly matrixed and global team * Experience with Class III Medical Devices ## Description We have an exciting opportunity for Senior System Design Quality Engineer supporting a cross-functional team on development and maintenance of capital equipment and software within the Interventional Cardiology (IC) division. This position will support an Imaging Guidance System, a significant product line with high visibility, which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls, software development lifecycle (SDLC), risk management, product development, regulatory and standards compliance, compliance, corrective and preventive actions, improvements for manufacturability, and cost-reduction efforts. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs., * Responsible for design control and risk management of next-generation medical devices * International standards compliance, including ISO 9001, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62304. * Uses clinical knowledge to influence how devices they are working on are tested and designed * Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues * Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects * Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) * Promotes and influences compliance to BSC's quality, business and health & safety systems and market/legal regulations * Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines). * Keeps up to date on all ISO/EN/FDA/MDR and other Product Development-related regulatory requirements and relays this information to the Product Development group * Participates in the implementation of product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V * Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. ## Related Videos - [What Production Knows: Closing the Loop Between AI Agents and the Systems They Build](https://www.wearedevelopers.com/videos/100277-what-production-knows-closing-the-loop-between-ai-agents-and-the-systems-they-build) - [Building the Next Generation of Software](https://www.wearedevelopers.com/videos/100186-building-the-next-generation-of-software) - [Official Opening of WeAreDevelopers World Congress 2026](https://www.wearedevelopers.com/videos/100000-official-opening-of-wearedevelopers-world-congress-2026) - [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) - [How to Survive The Worst Launch of Your Career with Brenda Romero](https://www.wearedevelopers.com/videos/609-how-to-survive-the-worst-launch-of-your-career-with-brenda-romero) - [How to add test automation to your project: The good, the bad, and the ugly](https://www.wearedevelopers.com/videos/1668-how-to-add-test-automation-to-your-project-the-good-the-bad-and-the-ugly) ## 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) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [The Ultimate Software Engineer Career Path Guide for 2023](https://www.wearedevelopers.com/magazine/146-the-ultimate-software-engineer-career-path-guide-for-2023)