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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Software Design Assurance Engineer - **Company:** Hologic, Inc. - **Location:** Newark, NJ, United States - **Experience:** Expert - **Salary:** $97,600.0 - $152,700.0 - **Contract:** Permanent contract - **Skills:** Agile Methodology, Artificial Intelligence, Data Analysis, Software System Penetration Testing, Automation of Tests, Failure Mode Effects Analysis, Minitab, Systems Development Life Cycle, Requirements Management, Software Engineering, Software Systems, Verification and Validation (Software), Systems Integration, Software Verification, Software Security, Safety Critical Systems, Information Technology, Data Analytics, Software Version Control, Vulnerability Analysis - **Published:** July 28, 2026 - **Apply:** https://www.dice.com/job-detail/7742388d-9990-42e4-ae5b-602028a4c67b ## About the Role * In-depth understanding of medical device regulations (e.g., FDA, EU MDR, ISO 13485, IEC 62304) for Software as a Medical Device (SaMD) and embedded systems. * Strong grasp of the software development lifecycle (SDLC) and its application to safety-critical systems. * Expertise in risk management per ISO 14971, including Hazard Analysis and FMEA. * Familiarity with usability principles and IEC 62366 to enhance product safety and effectiveness. * Knowledge of regulatory and safety challenges for AI/ML in medical devices. * Proficiency in statistical software (e.g., Minitab) for data analysis., * Ability to mature Quality Management System (QMS) processes using Agile/iterative design controls. * Hands-on experience in full SDLC for safety-critical applications. * Defining and executing robust software verification and validation (V&V) strategies. * Integrating automated testing into CI/CD pipelines and leveraging data analytics for continuous improvement. * Advanced project documentation, requirements management, and version control. * Software security skills, including threat modeling, vulnerability assessments, and penetration testing. * Excellent communication for cross-functional collaboration and technical presentations. Behavior * Collaborative approach, working closely with cross-functional teams (R&D, Regulatory, Marketing, Manufacturing Engineering, Quality Engineering). * Leadership in guiding teams on best practices for software development and compliance. * Proactive in identifying process gaps, recommending improvements, and supporting continuous improvement initiatives. * Creative and effective problem-solving, ensuring innovative solutions without compromising quality or compliance. * Commitment to maintaining compliance with all regulatory requirements and internal policies., * Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or related discipline with 5+ years of medical device industry experience, or a Master's degree with 3+ years of experience. * Proven track record in applying medical device regulations and standards to software projects. * Experience in leading design assurance activities, risk management, verification, and validation throughout the product lifecycle. * Participation in new product development and sustaining product projects, ensuring clear scope and objectives are met. * Involvement in regulatory inspections and remediation initiatives. ## Description The Senior Software Design Assurance Engineer is responsible for ensuring the quality, safety, reliability, and regulatory compliance of medical device software throughout the product lifecycle. This role focuses on establishing and maintaining robust software design controls, driving rigorous verification and validation processes, and collaborating with engineering teams to deliver dependable and compliant software solutions for both standalone and embedded medical devices. ## Related Videos - [The Algorithm That Nearly Killed Me: When Testing Isn't Enough](https://www.wearedevelopers.com/videos/2110-the-algorithm-that-nearly-killed-me-when-testing-isn-t-enough) - [PySpark - Combining Machine Learning & Big Data](https://www.wearedevelopers.com/videos/44-pyspark-combining-machine-learning-big-data) - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [How Data is Shaping our Games](https://www.wearedevelopers.com/videos/176-how-data-is-shaping-our-games) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) ## Related Articles - [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) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [Navigating the AI Shift](https://www.wearedevelopers.com/magazine/629-navigating-the-ai-shift) - [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) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers)