Abbott
Healthcare
SeniorSoftwareDesignAssuranceEngineer
“Senior Software Design Assurance Engineer at Abbott. Skills: Software quality engineering, Design assurance, Risk management. Support product development. Execute software quality engineering methodologies”
Industry & Context.
Problem resolution systems
5% travel
What They're Looking For.
Must Have
Bachelor's degree in engineering, Minimum 5 years related work experience, Knowledge of regulations affecting medical software, Verbal and written communication skills
Nice to Have
Advanced degree, Previous quality engineering experience, Demonstrated use of quality tools/methodologies, Experience in broader enterprise business unit
What You'll Do.
Support product development
Execute software quality engineering methodologies
Maintain software quality engineering methodologies
Provide quality engineering support for software
Provide technical guides for software requirements
Provide quality system guides for software requirements
Provide quality oversight for software verification
Provide quality oversight for software validation
Review software test case protocols
Approve software test case protocols
Review software test case reports
Approve software test case reports
Review software development plans
Review system documentation
Review software documentation
Lead meetings to prioritize issues
Lead meetings to review issues
Lead meetings to approve action plans
Lead risk evaluation activities
Lead risk management activities
Conduct Risk assessments
Conduct product risk analysis
Mitigate software issues
Participate in technical reviews
Participate in management reviews
Ensure design plans are met
Ensure product design is met
Ensure deliverables are met
Represent quality engineering function
Approve designated design outputs
Provide quality oversight for non-product software validation
Assess need for validation
Prepare protocols for validation
Support protocols for validation
Prepare reports for validation
Support reports for validation
Support product cybersecurity assessments
Comply with US FDA regulations
Comply with country regulatory requirements
Comply with company policies
Comply with company procedures
Maintain partnership with team members
Maintain partnership with R&D
Provide guidance to QE team members
Oversee work of QE team members
Develop training for company personnel
Conduct training for company personnel
Lead quality system improvement activities
Assign additional responsibilities
How You'll Work.
Team & Collaboration
Cross-functional team members; R&D collaboration
Communication Scope
Verbal communication; Written communication
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