Lead Design Assurance Engineer

Newark, DE, United States

Marlborough, MA, United States

Are you passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking a **Lead Design Assurance Engineer** to play a pivotal role in new product development, ensuring that design controls, risk management, and global regulatory compliance are maintained from concept to product launch. In this role, you’ll work cross-functionally to define clear design requirements, oversee verification and validation processes, and champion continuous improvement initiatives. If you’re a strategic thinker with hands-on expertise in design assurance and a commitment to delivering safe, reliable, and durable medical devices, we want to hear from you!

**Knowledge:**

+ In-depth understanding of medical device regulations and standards, including ISO 13485, ISO 14971, IEC 62366, IEC 60601, 21 CFR Part 820, M...