Staff Risk Management Specialist

2 weeks ago

Saint Paul, Minnesota, United States Abbott Laboratories Full time
About Abbott Laboratories

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 Mission

We are committed to delivering high-quality products and services that improve the health and well-being of people around the world.

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.

Job Summary

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.

Key Responsibilities

  • 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 team
  • Develop and clearly articulate a product's safety case in terms of hazard mitigation strategy, safety requirements and required levels of reliability
  • Identify required verification and validation evidence supporting hazard mitigation strategies
  • 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.

Requirements

  • Bachelor level degree in Engineering or Technical Field
  • 8+ years Medical Device and/or Engineering experience
  • 4+ years Risk Management and/or Safety Engineering Experience
  • 4+Years Systems Engineering Experience
  • 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 projects
  • Strong technical writing skills
  • Experience with root cause identification and problem solving

Preferred Qualifications

  • Prior medical device experience
  • Advanced 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
  • Systems or clinical engineering experience
  • Experience with basic statistics and/or reliability methodologies
  • Project Management experience
  • Audit back room or front room experience

What We Offer

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) PPO
  • An excellent retirement savings plan with 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 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.

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:

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, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $95,000.00 – $190, In specific locations, the pay range may vary from the range posted.

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