Design Assurance Engineer II — Medical Devices

Hologic, Inc.; Marlborough (MA); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic, Inc. in Marlborough, MA is seeking a Design Assurance Engineer 2 to provide design assurance support for new product development and on-market medical devices, ensuring design controls, verification and validation, risk management, and regulatory compliance throughout development and change activities.

You will collaborate with R&D and manufacturing teams to define requirements, validate methods, and maintain documentation, contributing to compliant, safe, and reliable products.

Qualifications

• Bachelor's degree in engineering or related field.
• 2+ years of experience in design assurance or regulated product development preferred.
• Experience with medical devices and regulatory standards is a plus.

Responsibilities

• Provide design assurance support for new product development and on-market medical devices.
• Facilitate application of design controls throughout product development and sustaining activities.
• Support regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
• Participate in ensuring design verification and validation activities meet requirements.
• Support test method validation as part of verification and validation.

Skills

Design controls

Risk management

Regulatory compliance

Verification & Validation

Documentation quality

Cross-functional teamwork

Analytical skills

Education

Bachelor's degree

Job description

Hologic, Inc. in Marlborough, MA is seeking a Design Assurance Engineer 2 to provide design assurance support for new product development and on-market medical devices, ensuring design controls, verification and validation, risk management, and regulatory compliance throughout development and change activities.

You will collaborate with R&D and manufacturing teams to define requirements, validate methods, and maintain documentation, contributing to compliant, safe, and reliable products.