Engineer II, Risk Management

Abbott

  • Saint Paul, MN
  • $60,000-120,000 per year
  • Permanent
  • Full-time
  • 10 days ago
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.JOB DESCRIPTION:Engineer II, Risk ManagementWorking at AbbottAt 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
student debt program, and 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 OpportunityThis position works out of our Tech center in Little Canada/St. Paul, MN as part of our 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 Engineer II, Risk Management, you’ll have the chance to assure new products perform the functions intended in a safe manner and establishes compliance with the quality system. You'll collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. You 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
  • 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
  • 2+ years’ experience in an engineering role
  • Hands-on experience in laboratory or production environment
Preferred Qualifications
  • Previous design quality engineering experience and demonstrated use of quality tools/methodologies
  • Advanced Degree
  • Prior medical device experience
  • 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
  • Experience facilitating risk assessments (e.g., FMEAs or FTAs)
  • 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 $60,000.00 – $120,000.00In specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: EP ElectrophysiologyLOCATION: United States
Minnesota
St. Paul
Tech Center : One St Jude Medical DriveADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Not specifiedMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott