Medical Device Design Assurance Engineer II

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

Job summary

Hologic, Inc. is seeking a Design Assurance Engineer 2 to support new product development and on-market devices. The role ensures design controls, risk management, and regulatory compliance are integrated into development and sustaining activities.

The candidate will collaborate with R&D, participate in V&V activities, and analyze product issues while coordinating health risk assessments for on-market products. A technical bachelor’s degree and 2+ years in medical devices are preferred.

Qualifications

• Technical Bachelor’s Degree required.
• 2+ years in the medical device industry preferred.
• Experience supporting regulated product development or design assurance is preferred.
• Knowledge of FDA QSR, ISO 13485, and ISO 14971 is preferred.

Responsibilities

• Provide design assurance support for new product development and on-market devices.
• Facilitate application of design controls throughout development and sustaining activities.
• Support regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
• Coordinate design verifications and validations to confirm requirements are met.

Skills

Design controls

Regulatory compliance

Risk management

Cross-functional coordination

Documentation

Analytical skills

V&V coordination

Education

Technical Bachelor's Degree

Tools

Statistical methods

Design of experiments

Root cause analysis

Verification & validation

Job description

Hologic, Inc. is seeking a Design Assurance Engineer 2 to support new product development and on-market devices. The role ensures design controls, risk management, and regulatory compliance are integrated into development and sustaining activities.

The candidate will collaborate with R&D, participate in V&V activities, and analyze product issues while coordinating health risk assessments for on-market products. A technical bachelor’s degree and 2+ years in medical devices are preferred.