Lead Design Assurance Engineer - Shape Safe Medical Devices

Hologic, Inc.; Marlborough (MA); On-site; USD 119,000 - 187,000; Full time

Job summary

Hologic, Inc. is seeking a Lead Design Assurance Engineer in the United States to drive design controls, risk management, and regulatory compliance from concept to product launch.

You will lead verification/validation, manage design inputs, and champion continuous improvement across cross‑functional teams. The role requires a strong background in medical device regulations, electro‑mechanical devices, and capital equipment, with 8+ years of industry experience or 5+ years with a Master’s degree.

Qualifications

• Deep knowledge of medical device regulations and standards (ISO 13485, ISO 14971, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP)
• Experience with electro‑mechanical devices and capital equipment
• Strong design inputs/requirements analysis, verification/validation, and design transfer experience
• Advanced risk management, hazard analysis and FMEA (Design, Usability, and Process)
• Proficiency in test method validation, statistics, and root-cause investigations

Responsibilities

• Define clear design requirements from concept to launch.
• Oversee verification/validation and design transfer activities.
• Champion continuous improvement initiatives to enhance product quality and compliance.
• Collaborate with R&D, Regulatory Affairs, and Manufacturing to ensure alignment on design and regulatory goals.

Skills

Leadership

Regulatory knowledge

Risk management

Verification/Validation

Statistical analysis

Project management

Documentation

Cross-functional collaboration

Continuous improvement

Education

Bachelor of Science in engineering

Master’s degree preferred

Job description

Hologic, Inc. is seeking a Lead Design Assurance Engineer in the United States to drive design controls, risk management, and regulatory compliance from concept to product launch.

You will lead verification/validation, manage design inputs, and champion continuous improvement across cross‑functional teams. The role requires a strong background in medical device regulations, electro‑mechanical devices, and capital equipment, with 8+ years of industry experience or 5+ years with a Master’s degree.