Risk Management Engineer II

Responsibilities

• Support risk management activities from product concept through product obsolescence
• Create and update Risk Management Plans, Hazard Analyses, FMEAs, and Risk Management Reports
• Establish risk mitigation strategies and measurable product requirements
• Ensure verification and validation evidence supports planned risk mitigation
• Maintain Risk Management Files to ensure continued product acceptability based on post-market feedback
• Support CAPAs and respond to Notified/Regulatory Body inquiries
• Complete Document Change Request Reviews in a timely and objective manner

Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical field
• 2-5 years of experience in the medical device industry, preferably with Class III implantable cardiovascular products
• Previous experience in Quality Engineering or Risk Management
• Working knowledge of ISO 14971 and ISO 13485 standards
• Strong interpersonal and communication skills to work effectively in a matrixed, fast-paced environment

Preferred Qualifications

• Knowledge of Complaint Handling processes
• Working knowledge of EUMDR requirements
• Experience with basic statistics
• Clinical engineering experience

Benefits

• Career development opportunities within an international company
• Health Investment Plan (HIP) PPO medical coverage options
• Retirement savings plan with high employer contribution
• Tuition reimbursement and student debt assistance programs
• Access to FreeU education benefits

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, including diagnostics, medical devices, nutritionals, and branded generic medicines. We serve people in more than 160 countries with a mission to restore health and improve quality of life.