Design Assurance Engineer II – Medical Devices

DIRECT SALES, US; Marlboro (MA); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic seeks 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 are effectively implemented.

You will facilitate design controls across development and sustaining activities, support manufacturing-related design changes, and coordinate health risk assessments and risk documentation with R&D and cross-functional teams.

Qualifications

• 2+ years of experience preferred in the medical device industry.
• Technical Bachelor's Degree is required.
• Experience supporting regulated product development or design assurance is preferred.

Responsibilities

• Provide design assurance support for medical devices throughout development and on-market activities.
• Facilitate application of design controls throughout product development and sustaining activities.
• Support regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
• Participate in NPD projects by ensuring inputs are defined and verification/validation confirm requirements.
• Support test method validation as part of verification and validation activities.
• Collaborate with R&D to coordinate design elements of Risk Management files and ensure compliance with standards.
• Coordinate Health Risk Assessment activities for on-market products with guidance as needed.
• Analyze product issues and evaluate impact of change requests on design.

Skills

Design controls

Regulatory compliance

Risk management

Verification and validation

Requirements analysis

Documentation accuracy

Cross-functional collaboration

Communication

Education

Technical Bachelor's Degree

Job description

Hologic seeks 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 are effectively implemented.

You will facilitate design controls across development and sustaining activities, support manufacturing-related design changes, and coordinate health risk assessments and risk documentation with R&D and cross-functional teams.