Staff Risk Management Engineer

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

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

Apply Now

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.

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The base pay for this position is

In specific locations, the pay range may vary from the range posted.