Abbott
Healthcare
SoftwareDesignQualityEngineer
“Software Design Quality Engineer at Abbott. Skills: Software Design Quality, Cybersecurity Design Quality, Risk Management, Agile SDLC. Lead, execute, and support Quality Engineering deliverables. Support on-time execution of Quality Plans”
What You'll Achieve.
On-time completion of Quality Engineering deliverables; Measurably enhance medical device software and cybersecurity lifecycle activities
Industry & Context.
Detailed root-cause analyses; Prioritize and meet deadlines
Travel: Yes, 5 % of the Time, Continuous sitting for prolonged periods, Continuous standing for prolonged periods
What They're Looking For.
Must Have
Bachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience., Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality, Experience ensuring automation frameworks and scripts meet design control requirements, Experience with software configuration, and issue tracking tools and requirements tools such as Jira and Jama, Experience as team-member/lead in Agile SDLC projects/programs, Deep knowledge of various types of SDLC’s (V-Model, Iterative, Agile/Scrum, etc.), Experience working in a broader enterprise/cross-site business unit model, Working knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485, Ability to work in a highly matrixed and geographically diverse business environment., Ability to work within a team and as an individual contributor in a fast-paced, changing environment, Ability to work in a lab, and hands-on experience with medical device development, Ability to leverage and/or engage others to accomplish projects, verbal and written communications with ability to effectively communicate at multiple levels in the organization, Ability to multitask, prioritize and meet deadlines in timely manner, organizational and follow-up skills, as well as attention to detail
Nice to Have
Master’s level degree preferred, ASQ CSQE and ISTQB certifications desired, Experience working with test management tools such TestComplete, desired, Experience in code review/static analysis tool(s) to aide code review such as Coverity, desired, Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl, desired, Clinical/Hospital experience desired, Experience in software testing and verification/validation, including lead experience, desired
What You'll Do.
and support Quality Engineering deliverables
Support on-time execution of Quality Plans
Guide development and documentation of procedures
Support product recertifications
Perform CAPA management and investigations
Work within Agile software development lifecycle framework
Support usability and human factors engineering reviews
Coach and mentor team members on best practices
Participate in reviews for System and Software requirements
Review and approve test methods
protocols and results
Support activities related to software change management
Implement quality initiatives
Support all activities within the software development lifecycle
Ensure DHF content completion
and regulatory & standards
Support internal & external audit and related responses
Support the establishment of customer and product requirements
Complete document Change Request reviews
Support Company initiatives for Quality Management Systems
Comply with FDA regulations and other regulatory requirements
How You'll Work.
Team & Collaboration
Work within a team; Collaborate with product team; Engage others to accomplish projects; Communicate at multiple levels in the organization; Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Communication Scope
Verbal and written communications; Effectively communicate at multiple levels in the organization
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