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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Design Assurance Engineer 3 - **Company:** Hologic, Inc. - **Location:** Marlborough, MA, United States - **Experience:** Expert - **Salary:** $97,600.0 - $152,700.0 - **Contract:** Permanent contract - **Skills:** Verification and Validation (Software), GXP - **Published:** May 19, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=cd8b4e35cf18125e ## About the Role * Comprehensive understanding of design control, risk management, quality systems, and change management for regulated medical devices . * Deep familiarity with FDA Medical Devices 820 Quality System Regulation, ISO 13485, ISO 14971:2019, EU Medical Device Directive (MDD), and Medical Device Regulation (MDR) . * Working knowledge of Good Laboratory Practices, Usability, Reliability, Electrical Safety, and Software standards/regulations . * Expertise in requirements analysis, including development of testable and measurable specifications, as well as verification and validation for regulated products . * Integrated knowledge of product performance accuracy and clinical efficacy, supporting quality and compliance throughout the device life cycle . Skills * Ability to drive action in accordance with Deming Cycle (PDCA) principles . * Strong written, verbal, and technical communication skills; fluent English (written and verbal). * Effective presentation skills and ability to clearly communicate compliance assessments. * Ability to work on project teams and take leadership roles on critical tasks to ensure timely completion and resolution . * Proficient in test method validation, root cause failure analysis, statistical methods, and design of experiments . * Skilled in collaboration, teamwork, responsibility/accountability, organization/planning/time management, problem solving/creativity, strategic/analytic/critical thinking, flexibility, and adaptability. * Bilingual ability, ASQ Certified Quality Engineer, and Six Sigma certification are beneficial . Behaviors * Demonstrates sound judgment in selecting methods and techniques to solve diverse problems. * Functions as a seasoned, creative professional, resolving a wide range of issues independently . * Networks effectively with senior internal and external personnel within area of expertise. * Acts as a significant contributor in assessing product performance and clinical efficacy, prioritizing compliance to maximize quality and customer safety . * Champions continuous improvement and embeds quality and compliance into daily operations and strategic initiatives., * 5-8 years with a Bachelor's Degree in Engineering, Biomedical or related field preferred; 2-5 years with a Bachelor's in a Technical Field; 1-3 years with a Master's Degree; 0-1 years with a PhD . * Prior experience in medical device or other highly regulated industry. * Experienced with FDA 820 Design Control requirements, ISO 13485, ISO 14971:2019, EU MDD, EU MDR . * Experienced with Good Laboratory Practices, Usability, Reliability, Electrical Safety, and Software standards/regulations . ## Description Hologic is dedicated to ensuring the safety and effectiveness of medical devices that impact lives every day. As a Sr. Design Assurance Engineer, you will play a critical role in embedding quality, compliance, and safety into our products throughout their entire life cycle-from development to market and post-market follow-up. You'll leverage your technical expertise and collaborative skills to drive product excellence and regulatory compliance, championing quality at every step. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [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) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [Kettle and Pot or Peas in a Pod? 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