Design Assurance Engineer II – Medical Devices

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

Job summary

Hologic, Inc. in Marlborough, MA is seeking a Design Assurance Engineer 2 to provide design controls, verification and validation, risk management, and regulatory compliance across new product development and on-market devices.

You will collaborate with R&D, support design changes, analyze issues, and ensure documentation quality. A 2+ year background in medical device design assurance is preferred; a Technical Bachelor’s Degree is required. Base salary range shown with bonus eligibility.

Qualifications

• Must support design controls in a regulated medical device environment.
• Strong analytical skills to evaluate issues, risks and change impacts.
• Ability to coordinate cross-functional activities related to risk management and health risk assessments.

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 manufacturing-related design changes, regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
• Participate in new product development projects by ensuring product inputs are defined and design verification/validation confirms requirements.
• Support test method validation as part of verification and validation activities.
• Participate in sustaining product projects ensuring tasks stay on track with verification, validation, and risk management.
• Collaborate with R&D to coordinate design elements of Risk Management files and ensure standards compliance.
• Coordinate Health Risk Assessment activities for on-market products.

Skills

Design controls

Analytical skills

Cross-functional coordination

Project teamwork

Regulatory communication

Verification & validation

Education

Technical Bachelor's Degree

Job description

Hologic, Inc. in Marlborough, MA is seeking a Design Assurance Engineer 2 to provide design controls, verification and validation, risk management, and regulatory compliance across new product development and on-market devices.

You will collaborate with R&D, support design changes, analyze issues, and ensure documentation quality. A 2+ year background in medical device design assurance is preferred; a Technical Bachelor’s Degree is required. Base salary range shown with bonus eligibility.