Staff Risk Management Engineer

Abbott Laboratories; Saint Paul (MN); On-site; USD 119,000 - 199,000; Full time

Benefits offered by this job

Fast-paced environment

Tuition assistance

401(k) match

Health benefits

Paid time off

Training & development

Job summary

Abbott Laboratories in Saint Paul, MN, seeks a Staff Risk Management Engineer II to assure product safety and quality, collaborating across clinical, design, regulatory and post-market teams. You will maintain risk management files, perform risk assessments, and drive improvements in risk controls and traceability.

The role requires strong domain knowledge in medical devices and regulatory frameworks. The position emphasizes risk analysis, process excellence, and collaboration within a

Qualifications

• 5+ years? experience in risk management or quality engineering.
• Experience in a medical device or regulated environment.
• Experience working in a broad enterprise/cross-division model.

Responsibilities

• Ensure new products meet safety and quality requirements.
• Collaborate with clinical, design, regulatory, labeling and post-market teams.
• Maintain risk management documentation and traceability across hazards, risks and controls.
• Lead risk assessments (FMEAs/FTAs) and integrate cybersecurity risk with patient safety.

Skills

Quality tools usage

Cross-functional collaboration

Risk assessment

Statistical methods

Education

Bachelor's degree in Engineering or Technical Field

Tools

FMEA

FTA

ISO standards knowledge

Job description

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.

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 student debt program, and 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 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

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 programsincluding medical, dental, vision, wellness and occupational health programs

Paid time off

401(k)retirement savings with a generous company match

The stability of a companywith 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:

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.

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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.