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 103,000 colleagues serve people in more than 160 countries.
Abbott Structural Heart Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
WHAT YOU'LL DO
As a Senior Software Systems Engineer in Operations and Manufacturing, you will be responsible for the electronic lot history record (eLHR) system; Assisting with all aspects of eLHR Application and eLHR Reporting Applications. Site/Division central contact for all eLHR projects and initiatives. Primary liaison between the business areas (Operations, IT, and Quality). Applies Business and IT knowledge to work with IT to better utilize existing applications to find solutions to business or technical problems. System owner for the electronic lot history record which will provides advice, assistance and leadership in any area associated with the planning, upgrades, enhancements, and business support.
Primary Job Function:
System owner for eLHR which includes all aspects of maintaining, upgrading, debugging, training, and general business support for the system.
Assists with all aspects of eLHR application and eLHR reporting systems. Primary contact for any system projects or initiatives.
Primary liaison between the business areas (Operations, IT, and Quality). Applies Business and IT knowledge to work with IT to better utilize existing applications to find solutions to business or technical problems. System owner for the electronic lot history record which will provides advice, assistance and leadership in any area associated with the planning, upgrades, enhancements, and business support.
Applies Business and IT knowledge and experience to analyze requirements and develop test cases and provides required documentation to maintain validated state of applications
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Business process expert for inventory management, distribution, and International customer service. Translates information from requirement documents/discussions into viable test cases and executes testing. Develops system documentation (test plans/strategies, other SLC documentation) in support of validation activities Investigates alternatives, using existing applications or recommends alternate applications. Prepares, develops and conducts training on new or revised functionality. Communicate issues that may delay the project or otherwise subject the company to financial or regulatory risk.
Completes project tasks within time and budget constraints. Identifies and implements process improvements.
Additional eLHR SME Roles and Responsibilities:
eLHR System Administrator: Assist with all aspects of eLHR Application and eLHR Reporting Applications
Site/Division central contact for all eLHR projects and initiatives
Work involves several categories
- Business Process
- System Improvements
- Expert on eLHR functionality
- Understand function at design level
- Expert on manufacturing processes being used at site
- Represent accurately to IT staff when necessary
- Identify opportunities to improve operations via use of eLHR functionality
- Assist/direct engineers with LHRBM set up to resolve process issues
- Share/Encourage use of eLHR “Best Practices”
- Procedure owner for site
- Support eLHR questions/reviews during internal/external Audits (and follow up)
- Support CRs where eLHR input is required
- Expert in all eLHR functions and use scenarios
- Assist individual users with odd/novel software circumstances
- Line down scenarios
- Compliance/process questions
- Central communicator during eLHR down periods (planned or unplanned)
- Business – inform users of status, answer questions
- IT – inform IT of status, ensure adequate response during issue, follow up after event where necessary
System Improvements (eLHR and Reporting)
- Work with business to clearly define potential improvements
- Business case
- DMC Change Management process
- Work with design team to ensure requirements are implemented
- Review/approve design documentation associated with IT projects (as business representative)
- Test new functionality when in development to ensure meets needs
- Perform UAT
- Coordinate update of eLHR and business process documentation to incorporate new functionality
- Functionality via configuration (novel functions with minimal IT involvement)
- Identify opportunities and create “requirements”
- Ensure compliance with change control process
- Perform testing on objects to ensure requirements are met
- Train on use of new functions
- Update documentation required to define new objects (part of change control process)
- Oversee training for application
- Engineers (Unit Tracking)
- Oversee OEE training and use
- BluePrint Training to Configure eLHR
- Create accounts/add users
- Create new roles when appropriate
- Support new lines, new workstation accounts
- Minor business support activities (add defect types, support other eLHR “lists”
- Business Process
- System Improvements
EDUCATION & EXPERIENCE YOU'LL BRING
Bachelor’s Degree (Sciences/Technical) and 6+ years’ experience, or an equivalent combination of education and work experience.
Minimum Experience / Training Required:
* Medical Device or Pharma Industry experience preferred.
*Understanding of business lot history record requirements
WHAT WE OFFER:
At Abbott, you can have a good job that can grow into a great career. We offer:
- 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