Risk Management Engineer (Medical Devices)

Location: Remote in Illinois, United States

Salary: $79,000–$119,000 annual, plus bonus and/or incentive eligibility

Company

hirify.global develops and supports medical devices, cosmetics, and over-the-counter drugs through a growing worldwide organization.

What you will do

• Monitor, maintain, and enhance global risk controls by analyzing and normalizing quality data and major quality events.
• Manage an automated risk-based trending system to identify emerging risks and demonstrate control effectiveness.
• Build risk-based dashboards with subject matter experts for real-time decision-making and management reporting.
• Provide technical guidance on implementing risk controls and address inefficiencies in the global quality management system.
• Lead project timelines, track milestones, resolve issues, and communicate progress to management and project teams.
• Collaborate with R&D, manufacturing, post-market surveillance, and Regulatory Affairs throughout the product lifecycle.

Requirements

• Bachelor’s degree in biology, chemistry, engineering, statistics, or a related field.
• At least 2 years of QA/QE experience in a cGMP device environment.
• Experience across the device lifecycle, including design, production, use, and ISO 14971 risk management.
• Experience with data visualization or business intelligence tools such as Tableau, Power BI, or Qlik.
• Experience leading multiple complex projects and managing competing priorities independently and collaboratively.
• Strong oral and written communication skills.

Nice to have

• Master of Science in chemistry, biology, biotechnology, chemical manufacturing, or a related field.
• Six Sigma certification.

Culture & Benefits

• Competitive total rewards package.
• Continuing education and training opportunities.
• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for eligible employees.
• Inclusive workplace focused on belonging, diversity, and career growth.