Senior Design Assurance Engineer – Medical Devices

Hologic, Inc.; Massachusetts; On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic, Inc. is seeking a seasoned quality/regulatory professional to drive risk management, design controls, and product safety across the lifecycle in a fast‑paced environment in Massachusetts.

You will apply judgment to select methods and techniques and resolve issues creatively with limited day‑to‑day instruction. This role emphasizes PDCA, verification/validation, and regulatory standards (FDA 820, ISO 13485, ISO 14971, EU MDR).

Qualifications

• Belongs to Deming PDCA cycle and process improvement.
• Experience applying verification/validation to regulated products.
• Ability to develop measurable specifications from requirements.
• Conduct Health Risk Assessments for on-market devices.
• Perform risk assessments for both on-market and new development programs.

Responsibilities

• Drive action according to PDCA principles.
• Develop and validate testable specifications via requirements analysis.
• Participate in test method development and validation.
• Maintain records of testing strategies and outcomes.
• Collaborate with multifunctional teams to ensure compliance and safety.

Skills

PDCA implementation

Requirements analysis

Test method development

Health risk assessments

Risk management

Regulatory judgment

Education

Bachelor's degree in Engineering/Biomed/related

Master's Degree or PhD (plus)

Job description

Hologic, Inc. is seeking a seasoned quality/regulatory professional to drive risk management, design controls, and product safety across the lifecycle in a fast‑paced environment in Massachusetts.

You will apply judgment to select methods and techniques and resolve issues creatively with limited day‑to‑day instruction. This role emphasizes PDCA, verification/validation, and regulatory standards (FDA 820, ISO 13485, ISO 14971, EU MDR).