Staff Software Test Engineer

Procept Biorobotics-posted about 1 month ago
Full-time • Mid Level
San Jose, CA
501-1,000 employees
Miscellaneous Manufacturing
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Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are treated? Join us as a Senior Software Test Engineer to ensure software quality within a complex medical device product through the development and execution of software test plan by way of verification procedure based upon software and system specifications.

  • Support new product development and design modifications, ensuring compliance with PROCEPT BioRobotics' Quality Management System.
  • Serve as a technical resource across software requirements, verification and validation, process validation, usability, statistical analysis, and risk management.
  • Collaborate with Program Management to maintain compliance with Design Controls and Risk Management procedures, and deliver complete Design History Files.
  • Develop and implement quality and risk management plans to ensure product designs and processes consistently meet specifications and critical-to-quality standards.
  • Lead software automation initiatives, including framework development, automated test scripting, and tool validation.
  • Conduct and document software testing activities, including functional, integration, and automated test execution.
  • Review design and software requirements for clarity, accuracy, and verifiability, and provide feedback during code and design reviews.
  • Support documentation reviews to ensure design safety, consistency, and compliance with regulatory standards such as FDA QSR.
  • Log and track software issues through resolution while ensuring adherence to quality and regulatory expectations.
  • Maintain compliance with PROCEPT BioRobotics' Quality and EHS policies through active participation and training.
  • A Bachelor's or Master's degree in Engineering (or an equivalent technical field).
  • 8+ years of experience in software testing, with a strong foundation in automation.
  • Hands-on experience developing test frameworks and automated test scripts.
  • Proficiency in Python and C# programming languages.
  • Familiarity with GUI automation tools such as Squish, Selenium, or WinAppDriver.
  • Experience using source control tools (e.g., GitHub) and continuous integration environments (e.g., Jenkins).
  • Comfort working with test case management systems like JAMA and defect tracking tools like Jira.
  • Working knowledge of C, C++, GUI design, and Windows OS is a strong plus.
  • Experience collaborating in an Agile development environment.
  • A solid understanding of medical device quality and regulatory standards, including 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
  • Experience with medical device testing or development.
  • Experience with ISO 13485 and IEC 62304, and familiarity with FDA GMP.
  • PROCEPT's health and wellness benefits for employees are second to none in the industry.
  • We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!
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