Job Description
Job Overview:
JOB DESCRIPTION:
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 Software Validation and Cybersecurity Specialist works out of our Lake Forest, IL location in the Informatics Division of Abbott Rapid Diagnostics.
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
Software Validation and Cybersecurity Specialist
Key Responsibilities also include:
Effectively assess regulatory and validation requirements for computer systems within organization
Identify and develop all required computer system validation deliverables including but not limited to validation plan, user and functional requirements, regulatory requirements, test strategy, IQ/OQ, deployment plan, traceability matrix, validation summary and others
Ensures compliance to all relevant Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
Experience in ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer System Assurance
Provide verification/validation activities project estimates per the department operating procedures.
Develop, own and execute to well defined timeline and project plan
Create, develop, and report metrics on the ongoing and pipeline projects
Coordinate Cybersecurity and Data Integrity actions for sites
Identify gaps and actions with milestones
Ensure all milestones are achieved on time
Establish and execute to the escalation process for issues and concerns
Conduct product cybersecurity risk assessments in regulated industries such as healthcare (medical and diagnostic devices).
Evaluate the security of products, software, and systems for compliance with applicable standards (ISO 27001, NIST, EU Directives, FDA, etc.).
Assess and identify the impact of changes, updates, or new regulations on existing and new products, guiding teams on necessary implementations.
Collaborate with Systems Engineering, Software Development, Regulatory, and other stakeholders to develop and document cybersecurity controls.
Requirements
Bachelor degree in Computer Science, Information Technology, Healthcare Technology, Life Sciences, or related discipline. Knowledge of regulations and standards that affect the health care industry.
5+ years combined experience in software development, cybersecurity, validation, and/or quality systems in a medical device regulated environment.
Experience in product cybersecurity risk assessments in regulated industries like healthcare.
Experience with cybersecurity challenges and solutions specific to SiMD/SaMD products.
Knowledge of encryption technologies and secure coding practices.
Familiarity with network security protocols and technologies (e.g., SSL/TLS, VPNs, IPsec).
Experience with cloud security and securing cloud-based applications and infrastructure.
Experience with writing & executing all computer system validation deliverables
Ability to work on multiple projects and timelines concurrently in a global team set-up
Proven expertise in problem solving and identifying solutions in regulated environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
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.
The base pay for this position is
$75,300.00 – $150,700.00In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
CMI ARDx Cardiometabolic and Informatics
LOCATION:
United States > Lake Forest : J55
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT 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.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
