Staff Risk Management Engineer

Abbott•St. Paul, MN

5d•$99,300 - $198,700•Onsite

About The Position

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. 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.

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

Nice To Haves

Advanced Degree
Medical Device and medical device software experience preferred
Experience working in a broader enterprise/cross-division business unit model
Working understanding of FDA, GMP, and ISO 13485
Working understanding of the following standards: ISO14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993, and/or ISO 14155
Systems or clinical engineering experience
Experience with basic statistics and/or reliability methodologies
Experience facilitating risk assessments (e.g., FMEAs or FTAs)

Responsibilities

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.

Benefits

Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
A fast-paced work environment where your safety is our priority
Production areas that are clean, well-lit and temperature-controlled
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities