Design Assurance Engineer 3

Job 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. Knowledge: - 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 qualit...