Design Assurance Lead – Medical Devices

Hologic, Inc.; Newark (DE); On-site; USD 119,300 - 186,600; Full time

Job summary

Hologic, Inc. in Newark, Delaware is looking for a Lead Design Assurance Engineer to ensure compliance and quality in medical device development. This role involves defining design requirements, overseeing verification processes, and driving continuous improvement initiatives.

The ideal candidate will have over 8 years of experience in the medical device industry, with a strong focus on design assurance and regulatory compliance. Relevant education and hands-on experience with electro-mechanical devices are also required.

Qualifications

• 8+ years of medical device experience with a Bachelor's, or 5+ years with a Master's degree.
• Hands-on experience with electro-mechanical devices preferred.
• Proven track record in design assurance activities and risk management.

Responsibilities

• Ensure design controls, risk management, and regulatory compliance for new products.
• Work cross-functionally to define design requirements and oversee validation processes.
• Champion continuous improvement initiatives across product lifecycle.

Skills

Leadership and mentoring skills

Strong analytical and problem-solving skills

Effective project management skills

Exceptional communication and collaboration skills

Proven ability to lead design assurance efforts

Education

Bachelor of Science in a related engineering discipline

Master’s degree preferred

Tools

Statistical analysis tools

Reliability modeling tools

Job description

Hologic, Inc. in Newark, Delaware is looking for a Lead Design Assurance Engineer to ensure compliance and quality in medical device development. This role involves defining design requirements, overseeing verification processes, and driving continuous improvement initiatives.

The ideal candidate will have over 8 years of experience in the medical device industry, with a strong focus on design assurance and regulatory compliance. Relevant education and hands-on experience with electro-mechanical devices are also required.