Senior Software Quality Engineer supporting Digital Health projects. Involved in software design quality assurance for medical device product development.
Responsibilities
Designed and tested prototypes and components.
Conducted root-cause analysis and problem-solving.
Translated design inputs into engineering specifications.
Developed software components and led code reviews.
Collaborated cross-functionally with R&D, Quality, Regulatory, and Marketing teams.
Requirements
Bachelor’s degree in a science or engineering.
Minimum of 2+ years of experience working in a highly regulated industry in following cGMP and GDP regulations.
Experience working through software lifecycle processes (Agile SAFe/Waterfall).
Experience with software Failure Modes Effect Analysis (sFMEA).
Proven ability to influence design quality across global, multidisciplinary teams.
Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations.
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