Senior Lead Risk Engineer - Medical Devices Quality

Hologic, Inc.; Marlborough (MA); On-site; USD 119,300 - 186,600; Full time

Benefits offered by this job

Comprehensive training

Career development opportunities

Bonus eligibility

Job summary

A leading medical technology company is seeking a Lead Risk Management Quality Engineer to ensure the safety and compliance of medical devices. This role involves leading risk management activities, improving processes, and mentoring teams. The ideal candidate has over 7 years of experience, a Bachelor’s degree in Engineering, and expertise in ISO risk standards. The company offers competitive compensation, with an annual salary ranging from $119,300 to $186,600, and is committed to enabling top talent through comprehensive training and development.

Qualifications

• 7+ years of experience in FDA-regulated industries.
• Deep expertise in ISO 14971:2019 and EU MDR.
• In-depth knowledge of FDA Quality System Regulations.

Responsibilities

• Lead risk management activities across the product lifecycle.
• Drive improvements to risk processes and procedures.
• Mentor teams in best-in-class risk practices.

Skills

Risk management documentation

Gap assessments

KPI development

Statistical analysis

Health Risk Assessments

Team leadership

Communication

Education

Bachelor’s Degree in Engineering

Job description

A leading medical technology company is seeking a Lead Risk Management Quality Engineer to ensure the safety and compliance of medical devices. This role involves leading risk management activities, improving processes, and mentoring teams. The ideal candidate has over 7 years of experience, a Bachelor’s degree in Engineering, and expertise in ISO risk standards. The company offers competitive compensation, with an annual salary ranging from $119,300 to $186,600, and is committed to enabling top talent through comprehensive training and development.