Senior Design Assurance Engineer – Medical Devices

Hologic, Inc.; Marlborough (MA); On-site; USD 97,600 - 152,700; Full time

Job summary

Hologic, Inc. seeks an experienced quality/regulatory professional to support medical device quality and safety throughout the product lifecycle.

You will apply judgment to resolve complex issues with limited day-to-day instruction, and collaborate on design controls, risk management and post-market activities. Responsibilities include verification and validation, test method development, health risk assessments, and cross-functional collaboration to ensure FDA 820, ISO 13485 and MDR compliance.

Qualifications

• Extensive knowledge of medical device quality systems and regulatory requirements.
• Experience with FDA 820, ISO 13485, ISO 14971 and MDR regulations is required.
• Proven ability to conduct risk management, design controls, and post-market surveillance.

Responsibilities

• Lead verification and validation activities for regulated products.
• Develop and document test methods and assess results with traceability.
• Perform Health Risk Assessments and document risk controls.
• Support internal and external audits, CAPA, SSEs and regulatory compliance.

Skills

Quality systems

Regulatory compliance

Verification & Validation

Risk management

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering or related field

Master’s Degree or PhD (preferred)

Tools

Quality Management Systems (QMS)

Job description

Hologic, Inc. seeks an experienced quality/regulatory professional to support medical device quality and safety throughout the product lifecycle.

You will apply judgment to resolve complex issues with limited day-to-day instruction, and collaborate on design controls, risk management and post-market activities. Responsibilities include verification and validation, test method development, health risk assessments, and cross-functional collaboration to ensure FDA 820, ISO 13485 and MDR compliance.