Senior Design Assurance Lead – Medical Devices

DIRECT SALES, US; Newark (DE); On-site; USD 119,000 - 187,000; Full time

Job summary

Hologic is seeking a Lead Design Assurance Engineer to drive design controls, risk management, and regulatory compliance from concept through launch in Newark, Delaware. This role demands leadership across cross‑functional teams and hands‑on expertise in design assurance and medical device development.

The position requires experience with verification/validation, FMEA, test methods, and a proven track record of delivering safe, reliable devices.

Qualifications

• Bachelor's degree in a related engineering discipline required.
• Master's degree preferred.
• 8+ years of medical device industry experience or 5+ years with a Master’s degree.
• Hands-on experience with electro-mechanical devices and capital equipment.
• Proven track record in design assurance activities, including verification/validation, risk management, and regulatory compliance.
• Demonstrated expertise in test method validation, statistical analysis, and root cause failure investigations.

Responsibilities

• Lead design assurance efforts across the product lifecycle from concept to post-market.
• Oversee verification and validation processes and design transfer activities.
• Champion continuous improvement to optimize product quality and compliance.
• Collaborate with cross-functional teams including R&D, Regulatory Affairs, and Manufacturing.
• Mentor junior engineers and foster a culture of quality.

Skills

Design assurance

Project management

Analytical thinking

Communication

Collaboration

Mentoring

Continuous improvement

Leadership

Education

Bachelor's degree in engineering

Master's degree preferred

Job description

Hologic is seeking a Lead Design Assurance Engineer to drive design controls, risk management, and regulatory compliance from concept through launch in Newark, Delaware. This role demands leadership across cross‑functional teams and hands‑on expertise in design assurance and medical device development.

The position requires experience with verification/validation, FMEA, test methods, and a proven track record of delivering safe, reliable devices.