Staff Risk Management Engineer

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

Benefits offered by this job

Fast-paced environment

Career development

Financial security

Health and wellness programs

Paid time off

401(k) retirement plan

Job stability

Job summary

Abbott Laboratories in St. Paul, MN is seeking a Risk Management Engineer II to ensure new Electrophysiology medical devices meet safety and quality standards. You will collaborate with clinical, design, regulatory, and post-market teams to mitigate risk.

Responsibilities include leading risk analyses (FMEA/FTA), maintaining risk-management traceability, supporting CAPA, and integrating cybersecurity risk with patient safety considerations. This is a full-time on-site role within EP division.

Qualifications

• Bachelor level degree in Engineering or technical field.
• 5+ years of experience in risk management or quality engineering.
• Experience in a cross-division enterprise model.
• Knowledge of FDA, GMP, and ISO 13485 preferred.

Responsibilities

• Risk management engineer II ensures new products perform safely and meet the quality system.
• Support risk management plan development and system hazard analyses (FMEAs/FTAs).
• Analyze legacy inputs and integrate cybersecurity risk with patient safety implications.
• Maintain traceability among hazards, risks, risk analyses, evaluations and controls.
• Lead post-market signal responses and updates to risk management files.

Skills

Risk management

Quality tools

Cross-functional work

CAPA knowledge

Education

Bachelor level degree in Engineering or Technical Field

Tools

FMEA / FTA

ISO/FDA awareness

Job description

Location United States - Minnesota - St. Paul Category Operations

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, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

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, MNlocation 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 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

Complaint analysis and related action planning/response

Backroom support for audits

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

At Abbott, you can have a good job that can grow into a great career. 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

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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.

Get tailored jobrecommendations based on your interests.

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, with leading businesses and

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, with leading businesses and

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, with leading businesses and

Job Id 31163752 LocationUnited States - Minnesota - St. Paul Medical surveillance No Division EP Electrophysiology Travel Yes, 5 % of the Time Additional Location 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)

CREATING POSSIBILITIES

INNOVATIVE BENEFITS

We support our colleagues around the world as they care for themselves and their families with offerings tailored to their unique needs.

DIVERSITY & INCLUSION

We strive to provide environments where all employees feel welcome and able to bring their full selves to work. To do this we integrate diversity, equity, and inclusion across Abbott.

SUSTAINABILITY FOR OUR FUTURE

At Abbott, sustainability means managing our efforts so we can help the greatest number of people around the world live fuller lives through better health.

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JOIN OUR TALENT COMMUNITY

We will notify you about relevant positions, and keep you in mind when we have interesting opportunities.

An Equal Opportunity Employer
Abbott is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Employment decisions are based on qualifications, merit, and business needs.
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We provide reasonable workplace accommodations. U.S. residents only: To request accommodation, please call 224-667-0340or email [e-mail] .
Abbott is committed to pay equity and transparency. Compensation is determined using objective, job-related, and gender-neutral criteria in compliance with applicable laws and local regulations.