Staff Risk Management Specialist

3 days ago

Saint Paul, Minnesota, United States Abbott Full time

The Opportunity

Abbott's Electrophysiology division is seeking a highly skilled Risk Management Engineer to join our team in St. Paul, MN. As a key member of our cross-functional team, you will play a critical role in ensuring the safety and effectiveness of our medical devices.

Key Responsibilities

  • Develop and implement risk management strategies to mitigate potential hazards and ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to identify and prioritize risks, and develop effective mitigation plans.
  • Conduct thorough risk assessments and develop safety cases to support product development and launch.
  • Ensure that all products meet the required levels of reliability and safety, and that all necessary verification and validation evidence is in place.
  • Support the development of quality plans and ensure that all projects are executed on-time and within budget.
  • Provide expert guidance and support to junior team members and contribute to the development of the team's risk management capabilities.

Requirements

  • Bachelor's degree in Engineering or a related field.
  • 8+ years of experience in medical device and/or engineering, with a minimum of 4 years in risk management and/or safety engineering.
  • Strong technical writing skills and ability to communicate effectively at multiple levels within the organization.
  • Ability to work in a highly matrixed and geographically diverse business environment.

Preferred Qualifications

  • Prior medical device experience.
  • Advanced degree in a related engineering field.
  • Working understanding of FDA, GMP, EU MDR, and ISO 13485.
  • Experience with root cause identification and problem-solving.

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