Design Assurance Engineer 3

Hologic • Newark, DE

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 .

Nice To Haves

• Bilingual ability, ASQ Certified Quality Engineer, and Six Sigma certification are beneficial .

Benefits

• We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees