Job Description

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, MDD 93/42/EEC, EU MDR, and MDSAP.
  • Familiarity with reliability modeling and testing for electro-mechanic...

    • Apply for this Position

    Ready to join Hologic, Inc.? Click the button below to submit your application.

    Submit Application