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Cybersecurity Design Quality Engineer

2 months ago

Westford, Massachusetts, United States Abbott Full time
About the Role

At Abbott, we are seeking a highly skilled Software Quality Assurance Engineer to join our team in the Abbott Vascular Division. As a key member of our Quality Engineering team, you will play a critical role in ensuring the quality and reliability of our medical devices.

Key Responsibilities
  • Lead and execute Quality Engineering deliverables from product concept through commercialization, including risk management activities (RMF, FMEA, Cybersecurity Risk Assessment)
  • Support on-time execution of Quality Plans and guide development and documentation of standard operating procedures, specifications, and test procedures
  • Manage CAPA activities, including thorough investigations, root-cause analyses, and implementation of corrections and corrective actions
  • Work within Agile software development lifecycle framework and 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
  • 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
Requirements
  • Bachelor's degree in Computer Science, Biomedical Engineering, Software Engineering, or a closely related discipline
  • Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality, and medical devices
  • Experience with ISO 14971 and FMEA
About Abbott

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.

What We Offer
  • A fast-paced work environment where your safety is our priority
  • Training and career development, with on-time 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 and 401(k) retirement savings with a generous company match