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.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition 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 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.

The Staff Risk Management Engineer assures new or modified products perform their intended functions in a safe and effective manner and establishes compliance with the quality system.  They organize and drive 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.  Successful skills and behavior include:

Planful, well-organized delivery of complex tasks and projects.Ability to work across a broad set of technologies with specialist to form a competent risk management project teamDevelop and clearly articulate a product’s safety case in terms of hazard mitigation strategy, safety requirements and required levels of reliabilityIdentify required verification and validation evidence supporting hazard mitigation strategiesSupport DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gapsMaintain Risk Management deliverables to ensure continued acceptability of products based on post market feedbackSupport on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projectsSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Collaborative style based on excellent communications and engagement skillsDecision making, driven by expert opinion and critical thinkingResults oriented, anticipation of issues/opportunities and proactivityCoaching and mentoring of juniors and life-long learner

Required Qualifications

Bachelor level degree in Engineering or Technical Field8+ years Medical Device and/or Engineering experience4+ years Risk Management and/or Safety Engineering Experience4+Years Systems Engineering ExperienceAbility to work in a highly matrixed and geographically diverse business environmentStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationAbility to leverage and/or engage others to accomplish projectsStrong technical writing skillsExperience with root cause identification and problem solving

Preferred Qualifications

Prior medical device experienceAdvanced Degree in related engineering fieldWorking understanding of FDA, GMP, EU MDR and ISO 13485Working understanding of the following standards: ISO 14971, ISO/TR 24971, IEC 60601, IEC 62304, IEC 62366, ISO 14155, ISO 10993, SW96Systems or clinical engineering experienceExperience with basic statistics and/or reliability methodologiesProject Management experienceAudit back room or front room experience

Apply Now

 

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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.

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 $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.