Design Assurance Engineer II – Medical Devices & Compliance

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

Job summary

Hologic Marlborough, MA, is seeking a Design Assurance Engineer 2 to provide design assurance support for new product development and on-market medical devices. You will help apply design controls, verification, validation, and risk management throughout the product lifecycle.

The role emphasizes collaboration with R&D, regulatory teams, and manufacturing to ensure compliance with FDA QSR, ISO 13485, and ISO 14971, while supporting design changes and test method validation.

Qualifications

• Technical Bachelor’s Degree is required.
• 2+ years of experience preferred, ideally in the medical device industry.
• Experience supporting regulated product development, sustaining engineering, or design assurance activities is preferred.

Responsibilities

• Provide design assurance support for new product development and on-market medical devices.
• Facilitate application of design controls throughout product development and sustaining product activities.
• Support manufacturing-related design changes, regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
• Participate in new product development projects by ensuring product inputs are clearly defined and that design verification and validation activities confirm requirements are met.
• Support test method validation as part of verification and validation activities.
• Coordinate Health Risk Assessment activities for on-market products, with manager or lead support as needed.
• Assess product change requests for design impact and determine required supporting documentation for implementation.

Skills

Design controls and V&V

Risk management

Regulatory compliance

Cross-functional collaboration

Analytical skills

Documentation accuracy

Education

Technical Bachelor's Degree

Job description

Hologic Marlborough, MA, is seeking a Design Assurance Engineer 2 to provide design assurance support for new product development and on-market medical devices. You will help apply design controls, verification, validation, and risk management throughout the product lifecycle.

The role emphasizes collaboration with R&D, regulatory teams, and manufacturing to ensure compliance with FDA QSR, ISO 13485, and ISO 14971, while supporting design changes and test method validation.