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 114,000 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 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 high employer contribution

• Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our St. Paul, MN location in the Electrophysiology division. 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.

As the Risk Management Engineer II, under the guidance of senior risk management team members, assures new or modified products perform their intended functions in a safe and effective manner and establishes compliance with the quality system. They participate in cross-functional collaboration with a broad cross-section of the organization to ensure that risk is appropriately defined, 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.

What You’ll Work On

• Learn and demonstrate proficiency of risk management process and use of supporting tools and methods.

• Participate in the risk management planning process to assure appropriate risk assessment input sources are identified and tasks executed based on project plan.

• Work effectively with a cross-functional team of experts in the execution of planned risk management activities.

• Working with senior risk management team members, learn and champion product’s safety case in terms of hazard mitigation strategy, safety requirements and required levels of reliability.

• Work with senior risk management team members to identify required verification and validation evidence supporting hazard mitigation strategies and communicate to stakeholders.

• Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.

• Maintain Risk Management deliverables to ensure continued acceptability of products based on post market feedback.

• Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.

• 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

• 3+ years Medical Device and/or Engineering experience

• 2+ years Risk Management or Design Assurance

• Ability to work in a highly matrixed and geographically diverse business environment

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

• Ability to leverage and/or engage others to accomplish project goals

• Strong technical writing skills

• Experience with root cause identification and problem solving

Preferred Qualifications

• Degree in related engineering field

• Working understanding of FDA, GMP, EU MDR, and ISO 13485

• Working understanding of the following standards: ISO 14971, ISO/TR 24971, IEC 60601, IEC 62304, IEC 62366, ISO 14155, ISO 10993, SW96

• Experience with basic statistics and/or reliability methodologies

Apply Now (https://www.jobs.abbott/us/en)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

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

The base pay for this position is $57,300.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com