Design Assurance Engineer 3

Hologic•Newark, NJ

11d

About The Position

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.

Requirements

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
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
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