Principal Engineer, Risk Management (Direct Hire)
Lake Forest, IL
Job Requisition: 6362
Description for Principal Engineer, Risk Management:
Lead technical contributor who monitors, maintains, and enhances the Medical Device Risk Management process. Execute the risk management process throughout the organization and the product lifecycle, including leading risk file remediation activities. Maintain the processes and procedures defining the execution of the risk management process and monitors the process based on performance metrics and standards and guidance documents.
Responsibilities for Principal Engineer, Risk Management:
- Provide SME level support of risk management across this medical device Company.
- Company leader for Risk Management with proven ability to own projects and advise on issues escalated to higher management
- Recommend procedure updates to support Medical Device Reporting (MDR) and EU MDR compliance
- Map strategy to move towards an automated Risk-based trending system
- Create framework for Risk-based dashboards to be used for more real-time decision making and management reporting
- Work cross-functionally throughout company to train and coach Risk Management process execution.
- Gauge the risk management system performance through review of data and metrics
- Identify inefficiencies in Risk Management system and drive improvements
- Present risk management program objectives, processes and metrics to upper management
- Own deliverables and commitments within the risk management process.
Requirements for Principal Engineer, Risk Management:
- Bachelor’s degree in Engineering Systems, Mechanical or Electrical required; Masters preferred
- 10+ years engineering experience required with demonstrated knowledge of Risk Management fundamentals
- Proficiency in ISO 14971 required
- Extensive experience in Medical Device Regulations (MDR) 2017/745
- Experience in medical device complaint handling
- Working knowledge of Quality System processes including Design Controls, CAPA, Complaints, Document Control, etc.)
- Experience leading a program or project full life cycle
- Working knowledge of Product Lifecycle Management (PLM) system approach to house Risk Management documentation and relation to Device Master Record (DMR)
- Deep knowledge of best practices Risk Management deployment
- Ability to develop database management strategies and metrics
- Experience interacting with and/or presenting to upper management
- ASQ-CMQ/QE Certification preferred.
- Experience in Agile and/or Oracle preferred