Design Assurance Engineer II — Medical Device Validation

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

Job summary

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

The role collaborates with R&D and project teams to define product inputs, ensure verification and validation meet requirements, and support health risk assessments for on-market products,

Qualifications

• Experience applying design controls to medical device development and sustaining activities.
• Ability to review and ensure compliance of project documentation.
• Familiarity with FDA QSR, ISO 13485, and ISO 14971 risk management requirements.
• Knowledge of verification and validation requirements for regulated products.

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.
• Coordinate design elements of Risk Management files with R&D and project teams.
• Assist in health risk assessment activities for on-market products as needed.
• Analyze product issues, define problems, and evaluate impact for change requests.

Skills

Design controls

Regulatory compliance

Risk assessment

Verification & validation

Documentation

Cross-functional collaboration

Communication

Education

Technical Bachelor's Degree

Job description

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

The role collaborates with R&D and project teams to define product inputs, ensure verification and validation meet requirements, and support health risk assessments for on-market products,