Staff Risk Management Engineer
Abbott
Summary
This position works out of our St Paul, MN location for our Electrophysiology Medical Device business. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
Job description
What You'll Work On
Risk Management Engineer II assures new products perform the functions intended in a safe manner and establishes compliance with the quality system. They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
- Support/execute risk management plan
- Support system/product risk management planning
- Support the requirements development process to assure quality of requirements and linkage to risk management file
- Support System Hazard Analysis; support risk assessments (FTAs, FMEAs); Analyze and incorporate legacy inputs; coordinate/integrate cybersecurity risk with patient safety implications
- Assure and maintain traceability among hazards, risks, risk analyses, evaluations and risk controls, and verification of implementation and effectiveness of risk controls
- Support writing of system/product risk management reports
- Be point of contact for tracking and developing response to post market signals (event-based and periodic) and lead resulting risk management file updates
- Including annual risk file updates
- Complaint analysis and related action planning/response
- Backroom support for audits
- Develop proficiencies in primary risk assessment tools (e.g., FMEA, FTA)
- Identify opportunities for improvement and drive/support process/infrastructure changes
- Identify/support process improvements driven by changes to external regulations, standards, or guidance or by internal Abbott Quality Policies
- Support CAPA efforts with linkages to Risk Management Process or Execution
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Requirements
- Bachelor level degree in Engineering or Technical Field
- 5+ years' experience
- Previous design quality engineering experience and demonstrated use of quality tools/methodologies
- Experience working in a broader enterprise/cross-division business unit model
Benefits
- Medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
- Paid time off
- 401(k) retirement savings
- Dental insurance
- Vision insurance
- Wellness programs
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.