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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Sr. Design Assurance Engineer - **Company:** HISTOSONICS INC - **Location:** Plymouth, MN, United States - **Experience:** Expert - **Salary:** $110,000.0 - $140,000.0 - **Contract:** Permanent contract - **Skills:** Adobe InDesign, Firmware, Software Product Management, Software Safety, Scaled Agile Framework, Software Engineering, Verification and Validation (Software), Systems Architecture, Software Verification - **Published:** July 17, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=5411ad2ea97ccb10 ## About the Role * Bachelor's degree required. * 5+ years of quality engineering experience in a Manufacturing environment, preferably in a medical device. * Strong experience with the medical device software/firmware development life cycle and software design assurance in accordance with IEC 62304. * Familiarity with SAFe AGILE Framework for software development cycle. * Ability to work within a team and as an individual contributor in a fast-paced, changing environment. * Strong analytical, critical thinking, and problem-solving skills with attention to detail and organizational goals. * Basic understanding of electrical and mechanical engineering principles; preferably an understanding of ultrasound physics. * Experience with verification and validation testing, risk management, design control, and Quality Management Systems. * Experience with FDA Quality System Regulations, ISO 13485 and EU MDR, ISO 14971, IEC 60601 series, IEC 62304, IEC 62366. ## Description The Sr. Design Quality Assurance Engineer will support design assurance activities and initiatives supporting Product Development projects including establishing and improving product design requirements, design review activities, risk management and the development of testing requirements. This role will work with new product development teams to assess product designs as well as working with the team on establishing product design requirements and a strategy for evaluating and demonstrating conformance to the requirements. This role has a particular emphasis on medical device software developed under IEC 62304, while retaining the flexibility to support hardware and system-level design assurance based on company needs. Key Responsibilities * Work with Regulatory, R&D, Engineers, and Product Developers in defining product design requirements and verification/validation methodology and acceptance criteria. * Work with Product Developers to ensure system architecture and testability of products is maintained. * Supports adherence to Design Controls throughout product lifecycle. * Support software design assurance across the software development life cycle, including software safety classification, software verification and validation, and software risk management in accordance with IEC 62304 and ISO 14971. * Support for product safety risk management (human factors, HW/SW design, process); identifies and implements systemic improvements and supports post-production risk management activities. * Provide technical expertise in review of product design documentation and specifications. * Support Design Reviews. * Review design history files to assure technical accuracy, completeness and compliance with applicable internal, regulatory and customer requirements. * Provide guidance to continuously improve design and development processes. * Provide guidance to engineers and product developers on compliance to applicable industry/regulatory product design/performance standards and lead activities to verify standards compliance. * Support for non-product software and automated systems used in design, operations and manufacturing processes; identifies and implements systemic improvements. * Assist in performing usability engineering activities including defining usability evaluation protocols. * Participate as a member of new product development teams to influence design robustness, reliability, and safety through application of sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving/preventing design quality issues. * Provide input into inspection strategy and plans including working with suppliers on purchased product requirements and development of measurement methodologies. * Support the transfer of specifications and processes to production during design transfer phase. * Assist in developing design verification and validation plans, protocols and reports. * Participate in troubleshooting and risk assessment of issues with design team to identify root cause and resolution. * Supports Subject Matter Experts (SME's) during audits and inspections for risk management and non-product software validation processes. * Participate in continuous improvement of the Quality Management System. * Maintain safe and clean work environment. ## Related Videos - [Psychological Safety in Software Engineering - Jenny-Margrethe Vej & Alexandra Hou Aldershaab](https://www.wearedevelopers.com/videos/2142-psychological-safety-in-software-engineering-jenny-margrethe-vej-alexandra-hou-aldershaab) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Playing Pong on a shoulder press machine](https://www.wearedevelopers.com/videos/100140-playing-pong-on-a-shoulder-press-machine) - [Building a hypercar from scratch](https://www.wearedevelopers.com/videos/607-building-a-hypercar-from-scratch) - [Mutation Testing and Fuzzing in C#](https://www.wearedevelopers.com/videos/703-mutation-testing-and-fuzzing-in-c) - [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 - [How Developers Can Focus on Maintaining Satisfaction With Accessibility](https://www.wearedevelopers.com/magazine/109-how-developers-can-focus-on-maintaining-satisfaction-with-accessibility) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [How software is steering vehicle technology](https://www.wearedevelopers.com/magazine/515-how-software-is-steering-vehicle-technology) - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers)