Magic Leap’s mission is to harmonize people and technology to create a better, more unified world. Magic Leap is a team of creatives and technologists building a personal, spatial computing platform that seamlessly blends the digital and physical worlds. Magic Leap’s healthcare team is changing the world of consumer well-being, diagnostics, and digital therapeutics, and is looking to expand its team.

Job Description

In this role, you will have the opportunity to utilize your broad skills as a Quality Engineer, and apply them to development for Magic Leap digital health software solutions. Responsibilities include implementing, auditing, and improving quality systems, as well as designing protocols for medical device level testing and collecting, processing and reviewing test data with software development teams. Strong attention-to-details and execution skills are essential to succeed in this role.

Responsibilities

  • Own and implement a medical device software quality assurance plan
  • Develop, modify and evaluate software test planning documentation and protocols used to design, implement, test, and optimize software on multiple projects
  • Drive the execution of functional and system level testing of software components
  • Perform end-to-end integration and regression testing and create relevant reports of healthcare-related software and cloud services and apps
  • Create new tests to target new features and products, ensuring fulfillment of applications and use cases and feature requirements
  • Debug and investigate defects to determine root cause and perform failure analysis, including root cause defect investigations
  • Partner with cross-functional software and hardware teams on corrective and preventative actions plans
  • Coordinate with other quality assurance teams within the company to synchronize evaluation and testing procedures and processes
  • Coordinate with regulatory team to ensure that quality processes meet FDA and other applicable regulations
  • Conduct internal verification audits
  • Develop and deliver quality training to software developers

Qualifications

  • Experience in FDA Medical Device Quality Management System specifically related to software
  • Experience with all FDA Guidance related to medical device software, mobile medical applications, cybersecurity, IEC 62304
  • 6+ years of experience in software testing or software development, with experience in agile development a plus
  • Experience with version control (especially Git-based), continuous integration and automated testing (e.g. Jenkins, Maven)
  • Direct experience in performing quality testing in high tech, fast-paced software development environment.
  • Ability to write reports, draft work instructions, and present results to management
  • Continuous improvement mindset with focus on customer expectations and product quality
  • Dynamic and “can do” attitude individual with the desire to work with a great team and product
  • Ability to manage & complete multiple tasks simultaneously
  • Must possess a high level of attention to detail with handling of samples and test data
  • Experience with data analysis and software tools is preferred
  • Experience with HIPAA, GDPR strongly preferred

Education

  • BS/BA in Computer Science or Computer Engineering; MS preferred

Additional Information

  • All your information will be kept confidential according to Equal Employment Opportunities guidelines.
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