Senior Software Quality Design Engineer

6 hours ago


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

We are seeking a highly skilled Senior Software Quality Design Engineer to join our team at Abbott Laboratories. As a key member of our Quality Engineering team, you will be responsible for leading the development and execution of quality engineering deliverables for our medical devices.

Key Responsibilities
  • Lead the development and execution of quality engineering deliverables, including risk management activities, quality plans, and standard operating procedures.
  • Support the execution of quality plans and ensure timely completion of quality engineering deliverables.
  • Guide the development and documentation of standard operating procedures, specifications, and test procedures.
  • Support product recertifications and CAPA management, including thorough investigations and root-cause analyses.
  • Work within an 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 product lifecycle testing.
  • 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 other functional groups.
  • 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 6+ years of combined experience in software design quality, cybersecurity design quality, and medical devices software experience.
  • Experience with ISO 14971 and FMEA is required.
About Abbott Laboratories

Abbott Laboratories 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.

We offer a fast-paced work environment where your safety is our priority, training and career development, financial security, and health care and well-being programs. Join our team and grow your career with a company that can help you build your future and live your best life.



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