Risk Management Engineer

Key contributor within the organization that monitors, maintains, and enhances risk controls for medical devices, cosmetics, and OTC drugs, ensuring compliance with global regulations and supporting risk management throughout the product lifecycle.

Location: United States

Salary: $79,000.00 - $119,000.00 Annual

Responsibilities

• Analyze and normalize multiple streams of data to gauge the health of the risk management system.
• Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards for real-time decision-making and management reporting.
• Provide detailed input to stakeholders on how to implement risk controls and create and implement controls.
• Identify inefficiencies in Medline’s global quality management system and take action to address them.
• Develop timelines for projects and ensure deadlines and goals are met.
• Update management and team on progress.
• Work with division or project team members to identify issues that might delay projects and make recommendations to improve timelines.

Requirements

• Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree.
• At least 2 years of QA/QE experience in a cGMP Device or environment.
• Complete device life cycle experience related to design, production, use of a device, and ISO 14971.
• Experience with Data visualization tools/business intelligence tools such as Tableau, Power BI, or Qlik.
• Experience leading multiple, complex projects.
• Strong ability to manage multiple priorities.
• Self-starter attitude.
• Good oral and writing skills.
• Ability to work independently and as a team.

Benefits

• Health insurance
• Life and disability insurance
• 401(k) contributions
• Paid time off
• Access to Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.

Additional Information

• The position is bonus and/or incentive eligible.
• The salary varies based on location, education, experience, skills, and abilities.
• Medline offers a comprehensive benefits package and a growing worldwide organization.