Staff Risk Management Engineer

Thornton Tomasetti; Saint Paul (MN); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Tuition reimbursement

Health care programs

401(k) retirement savings with company

Paid time off

Job summary

Abbott's Electrophysiology (EP) business in Saint Paul, MN is seeking a Staff Risk Management Engineer II to assure new products perform safely and meet quality requirements. You will partner with clinical, design, regulatory, and post-market teams to mitigate risk and safeguard patient safety while enabling business goals.

In this role you will develop risk management plans, support hazard analyses and risk assessments (FMEA/FTA), maintain traceability, and drive risk file updates.

Qualifications

• 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.
• FDA, GMP, ISO 13485 knowledge preferred.

Responsibilities

• Develop and execute risk management plans for products.
• Coordinate risk management with clinical, regulatory, and design teams.
• Maintain traceability across hazards, risks, analyses, and controls.
• Prepare system/product risk management reports.
• Update risk management files annually and after post-market signals.
• Assist CAPA with links to Risk Management processes.
• Support audits and risk management process improvements.

Skills

Risk management

Quality tools/methodologies

Cross-functional collaboration

Analytical thinking

Documentation

Education

Bachelor's degree in Engineering or Technical Field

Advanced degree

Tools

FMEA

FTA

Job description

Staff Risk Management Engineer Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.
You’ll also have access to:

• 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.

The Opportunity

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.

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.

• Product Development – 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
• Risk Management Tool Mastery – develop proficiencies in primary risk assessment tools (e.g., FMEA, FTA)
• Support Risk Management Process Excellence – 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.

Required Qualifications

• 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

Preferred Qualifications

• 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)

What We Offer

• 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

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Engineering

DIVISION: EP Electrophysiology

LOCATION: United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 5% of the Time

MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on X @AbbottNews.