Senior Design Assurance Engineer: Medical Device Risk

DIRECT SALES, US; Marlboro (MA); On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic, Inc. seeks an experienced professional to tackle complex problems, applying judgment to methods while ensuring quality and safety across the product lifecycle. The role emphasizes regulatory compliance, risk management, and design controls within a highly regulated medical device environment.

The candidate should have extensive knowledge of FDA QSR 820, ISO 13485, ISO 14971, and EU MDR requirements, with strong leadership and communication skills to guide cross-functional teams.

Qualifications

• Design controls applied to manufacturing and design changes.
• Risk management across the device lifecycle.
• Quality systems support for audits, CAPAs, SSEs, and post-market surveillance.
• Regulatory standards familiarity for FDA 820, ISO 13485, ISO 14971, MDR 2017/745.
• Verification and validation requirements for regulated products.

Responsibilities

• Lead critical tasks to ensure timely completion.
• Advise on risk management and product quality across lifecycles.
• Communicate assessments clearly to multi-disciplinary teams.
• Document testing strategies and outcomes accurately.

Skills

PDCA principles

Risk assessments

Verification & validation

Test method development

Communication skills

Leadership

Statistical methods

Design controls

Education

Bachelors in Engineering/Biomedical

Masters/PhD preferred

Job description

Hologic, Inc. seeks an experienced professional to tackle complex problems, applying judgment to methods while ensuring quality and safety across the product lifecycle. The role emphasizes regulatory compliance, risk management, and design controls within a highly regulated medical device environment.

The candidate should have extensive knowledge of FDA QSR 820, ISO 13485, ISO 14971, and EU MDR requirements, with strong leadership and communication skills to guide cross-functional teams.