Staff Risk Management Engineer
Job Location:
Saint Paul, MN - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Staff Risk Management Engineer
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. Youll 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 bachelors 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 MNlocation for our Electrophysiology Medical Device Abbotts Electrophysiology (EP) business were 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.
What Youll Work On
Risk Management Engineer II assures new products perform the functions intended in a safe manner and establishes compliance with the quality system. They collaborate with clinical design engineering regulatory labeling and post market surveillance functions to ensure that risk is appropriately 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.
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
5 years experience
Previous design quality engineering experience and demonstrated use of quality tools/methodologies
Experience working in a broader enterprise/cross-division business unit model
Preferred Qualifications
Advanced Degree
Medical Device and medical device software experience preferred
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 methodologies
Experience facilitating risk assessments (e.g. FMEAs or FTAs)
What We Offer
At Abbott you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your safety is our priority
Production areas that are clean well-lit and temperature-controlled
Training and career development with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation incentives and retirement plans
Health care and well-being programs including medical dental vision wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
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 X @AbbottNews.
The base pay for this position is
$99300.00 $198700.00In specific locations the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Staff IC
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
