Software Design Quality Engineer
Abbott Laboratories, Westford, MA, United States
Software Design Quality Engineer
We currently have an opening for a Software Design Quality Engineer for the Vascular division, located in Westford, MA. This is a fully onsite role.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for the treatment of vascular disease. Our extensive portfolio includes drug‑eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Main Responsibilities
Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA, Cybersecurity Risk Assessment)
Support on-time execution of Quality Plans
Guide development and documentation of standard operating procedures, specifications and test procedures
Support product recertifications
CAPA management – including (but not limited to) performing thorough investigations with detailed root‑cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria.
Work within Agile software development lifecycle framework
Support usability and human factors engineering reviews
Coach and mentor team members on best practices in design quality, and overall product lifecycle testing/quality engineering to establish product and system reliability. Accent on agile testing and automated testing practices
Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection
Review and approve test methods, protocols and test results provided by another functional group.
Support activities related to software change management and overall change management
Bring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activities
Support all activities, as needed by the business within the software development lifecycle.
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support internal & external audit and related responses
Support the establishment of objective, measurable and verifiable customer and product requirements
Complete document Change Request reviews in a timely and objective manner
Additional duties may be identified by functional management based on the current project/business objectives.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Perform other related duties and responsibilities, on occasion, as assigned.
Education and Experience You’ll Bring
Required Experience
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
Strong 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
Strong organizational and follow‑up skills, as well as attention to detail
Preferred Experience
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
Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.
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We currently have an opening for a Software Design Quality Engineer for the Vascular division, located in Westford, MA. This is a fully onsite role.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for the treatment of vascular disease. Our extensive portfolio includes drug‑eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Main Responsibilities
Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA, Cybersecurity Risk Assessment)
Support on-time execution of Quality Plans
Guide development and documentation of standard operating procedures, specifications and test procedures
Support product recertifications
CAPA management – including (but not limited to) performing thorough investigations with detailed root‑cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria.
Work within Agile software development lifecycle framework
Support usability and human factors engineering reviews
Coach and mentor team members on best practices in design quality, and overall product lifecycle testing/quality engineering to establish product and system reliability. Accent on agile testing and automated testing practices
Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection
Review and approve test methods, protocols and test results provided by another functional group.
Support activities related to software change management and overall change management
Bring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activities
Support all activities, as needed by the business within the software development lifecycle.
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support internal & external audit and related responses
Support the establishment of objective, measurable and verifiable customer and product requirements
Complete document Change Request reviews in a timely and objective manner
Additional duties may be identified by functional management based on the current project/business objectives.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Perform other related duties and responsibilities, on occasion, as assigned.
Education and Experience You’ll Bring
Required Experience
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
Strong 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
Strong organizational and follow‑up skills, as well as attention to detail
Preferred Experience
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
Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.
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