Staff Product Risk Mgr

About the position

The Staff Product Risk Manager at Draeger Medical Systems, Inc. is responsible for leading the risk management process throughout the development cycle of medical devices, ensuring compliance with ISO 14971 and enhancing product safety. This role involves collaboration with various engineering disciplines and product development teams to identify risks, implement control measures, and maintain product-related documentation. The position is critical in assessing product non-conformities and providing expertise in health hazard evaluations, ultimately contributing to improved product safety and performance.

Responsibilities

• Lead the risk management process throughout the development cycle, ensuring risks are identified and control measures are effective.
• Create and maintain product-related files and reports to support compliance and enhance product safety.
• Review post-market surveillance data to anticipate potential issues and inform stakeholders.
• Provide leadership and expertise to product development teams to ensure risk management principles are applied throughout the design process.
• Collaborate with various engineering disciplines to coordinate risk activities effectively.
• Influence product or system architecture and design to improve product safety.
• Assess product non-conformities and provide rationale for deferred defects.
• Provide risk expertise input to Health Hazard Evaluations to improve responses to field issues.

Requirements

• Bachelor's degree in engineering or clinical discipline; Master's degree is a plus.
• 5+ years of relevant experience in risk management for medical devices or regulated industries.
• 5+ years of experience in electromechanical device design.
• Solid understanding of risk sources and management.
• Proficiency in high-risk management tools, including FMEA, FTA, and FMECA.
• Knowledge of usability or human factors engineering for medical devices.
• Familiarity with regulatory standards such as UL, CSA, IEC/EN.

Nice-to-haves

• Experience in the field of thermoregulation and neonatal care.
• Knowledge of GMPs as defined by the FDA.
• Skilled in collaborating with multi-disciplinary teams.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Paid time off starting at 4+ weeks per year.
• Tuition reimbursement.
• 401k match.
• Wellness and employee support programs.
• Life insurance.