Senior Design Assurance Engineer – Medical Devices

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

Job summary

Hologic, Inc. is seeking a seasoned professional to support medical device quality, compliance, and safety across the product lifecycle.

You will analyze complex data, apply judgment, and resolve issues creatively with limited routine guidance. Key areas include design controls, risk management, quality systems, regulatory standards (FDA 820, ISO 13485, ISO 14971, MDR), verification and validation, and requirements analysis.

Qualifications

• Bachelor’s degree in engineering or related field required; advanced degrees preferred.
• Experience in medical device regulatory requirements and quality systems.
• Experience with FDA 820, ISO 13485, MDR/IVD regs.
• Experience with risk management and design controls.

Skills

Design controls

Risk management

Quality systems

Verification & Validation

Requirements analysis

Test method validation

Health Risk Assessments

PDCA / Deming Cycle

Written & verbal communication

Leadership in projects

Education

Bachelor's Degree in Engineering or related

Master's Degree or PhD is a plus

Job description

Hologic, Inc. is seeking a seasoned professional to support medical device quality, compliance, and safety across the product lifecycle.

You will analyze complex data, apply judgment, and resolve issues creatively with limited routine guidance. Key areas include design controls, risk management, quality systems, regulatory standards (FDA 820, ISO 13485, ISO 14971, MDR), verification and validation, and requirements analysis.