Senior SaMD Safety Risk Manager (ISO14971)

Merative; Ann Arbor (MI); Hybrid; USD 121,000 - 182,000; Full time

Benefits offered by this job

Remote-first culture

401k plan

Health, dental, vision insurance

Paid time off

Job summary

Merative is seeking a Senior Specialist, Product Safety Risk Management to lead ISO 14971-based risk management for medical imaging software across design, pre- and post-market phases. Collaborate with engineering, regulatory, clinical, cybersecurity, and human factors teams to identify, evaluate, and mitigate safety risks throughout the lifecycle.

The role requires deep knowledge of medical device software safety, the ability to influence across disciplines, and the creation and maintenance of

Qualifications

• Bachelor’s degree in engineering, computer science, life sciences, or equivalent.
• Advanced training in medical device safety risk management preferred.

Responsibilities

• Owns and maintains safety risk management processes across the product lifecycle.
• Coordinates hazard analyses, risk Assessments, and risk controls per ISO14971.

Skills

Risk management

ISO 14971

Cross-functional collaboration

Analytical thinking

Regulatory compliance

Hazard analysis

QA systems

Education

Bachelor’s degree in engineering or life sciences

Advanced training in medical device safety risk management

Tools

Jira

Xray Test Management

Microsoft 365

Job description

Merative is seeking a Senior Specialist, Product Safety Risk Management to lead ISO 14971-based risk management for medical imaging software across design, pre- and post-market phases. Collaborate with engineering, regulatory, clinical, cybersecurity, and human factors teams to identify, evaluate, and mitigate safety risks throughout the lifecycle.

The role requires deep knowledge of medical device software safety, the ability to influence across disciplines, and the creation and maintenance of