Software Quality Engineer I
Core
Ensures software products for mobile medical devices and connected digital health solutions are developed in accordance with quality system regulations, industry standards, and company procedures.
Role type
Software Quality Engineer I (medical device software)
Builds
Native mobile applications (iOS/Android), cloud-connected healthcare solutions, and related software systems
Domain
Healthcare / Medical Devices / Software Quality Engineering
Required skills
Software verification and validation, risk management (ISO 14971), defect management, test automation (Selenium, Appium, Postman), requirements traceability, regulatory compliance (FDA), Agile development, C/C#/Java/Python scripting, issue tracking (Jira, Azure DevOps, DOORS)
Preferred skills
Mobile application architecture (iOS/Android), regulated industry experience (medical devices, pharma, aerospace), medical device software standards (IEC 62304, IEC 62366), cybersecurity principles, cloud-connected systems
Technologies
iOS, Android, C, C#, Java, Python, Ruby, Perl, Selenium, Appium, Postman, GIT, Jira, Azure DevOps, ClearQuest, DOORS
Responsibilities
Support design quality activities including requirements reviews, risk management, and software verification and validation; Review software lifecycle deliverables and participate in design and release reviews; Evaluate software defects and assess product quality impacts; Participate in investigation and resolution of software-related quality issues; Support preparation and maintenance of Design History File (DHF) and software lifecycle documentation; Support internal and external audits
Seniority
Mid-level, hands-on IC