Manager, Risk Management and Patient Safety

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.

Manager, Risk Management and Patient Safety

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 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 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, 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 Manager, Risk Management and Patient Safety, you’ll be responsible for delivering the safest experience possible to our patients, while driving efficient, risk driven practices into both the Development and Product Stewardship processes.

This role will lead the evolution of the risk management discipline to efficiently direct the entire product lifecycle.   Future state will enable the organization to ‘design for safety’ from the system level through production controls starting with the design concept phase.  

The position is also responsible for leading the development and maintenance of RISK Management engineering methodologies and providing subject matter expertise within new product development, manufacturing, or system/services support. 

Responsibilities:

• Collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. 

• 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.

• Develop methods, tools, procedures to conduct risk management activities

• Creating a strategy and construct for how Risk Management tools like HA’s and FMEAs can synergistically exist and/or be incorporated into a holistic RM strategy.

• Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element and ensuring interfaces with research and development, manufacturing, post market surveillance and clinical functions.

• Interprets regulations and requirements and implements programs and procedures to meet requirements worldwide as they pertain to Risk Management.

• SME for domestic/international sites and affiliates regarding Risk Management Quality System elements.

• Directs project execution through resource planning, tracking project deliverables, identifying risks, and developing and executing contingency plans.

• Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units and sites.

• Serves as a representative during internal and external inspections and inquiries from regulators such as FDA; ISO; and AQR as it relates to product Risk Management.

• Responsible for Talent Development of organization related to Risk Management and its’ relationship with Systems Engineering.

• Update risk management files as necessary to incorporate clinical assessments and post market surveillance

Required Qualifications

• BS degree in Engineering or Technical Field or equivalent experience

• 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

• Advanced degree preferred

• Engineering experience and demonstrated use of Quality tools/methodologies

• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

• Prior medical device experience

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. 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 $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.

• risk management
• medical device regulations
• quality management systems
• project management
• technical writing
• root cause analysis
• cross-functional collaboration
• regulatory compliance
• systems engineering
• problem solving
• risk assessment tools
• fda regulations
• iso standards
• leadership skills
• communication skills
• team management
• strategic planning
• clinical assessments