Insulet Corporation-posted 2 months ago
$64,500 - $96,750/Yr
Full-time • Entry Level
Hybrid • Acton, MA
Miscellaneous Manufacturing

Insulet is looking for a motivated Associate Software QA Engineer to join our Pod DevOps, Tools, and Automation Team. This position assists in the software quality assurance efforts related to the validation of non-product custom tools, ensuring they meet the highest standards of quality and reliability for the Research and Development group. The position is responsible for ensuring that new tools have been effectively and efficiently verified and validated prior to their release and that these designs effectively meet documented and implied user needs and requirements. Software quality assurance efforts are lifecycle-oriented beginning during product requirements development and continuing throughout their lifetime. This position will also be part of validating software development tools to improve the overall quality of software, including peer reviews, software hazard analysis, requirements traceability, software code analysis, defect tracking, software metrics, and configuration management.

  • Develop and execute test plans and test cases for non-product custom tools.
  • Contribute to the validation of OTS, SOUP, and 3rd Party Tools for use in R&D.
  • Collaborate with software developers and other stakeholders to understand requirements and design effective validation strategies.
  • Collaborate with cross-functional teams, including software development, DevOps, Automation, and product management, to ensure tool quality and functionality.
  • Perform functional, regression, and performance testing on custom tools.
  • Identify, document, and track software defects and ensure their resolution.
  • Participate in requirement definition and design reviews and provide feedback on testability and quality.
  • Ensure compliance with industry standards and regulatory requirements.
  • Continuously improve testing processes and methodologies.
  • Provide clear and concise documentation of testing activities and results.
  • Perform other duties as required.
  • Self-motivated
  • Proactive
  • Quick learner
  • Strong understanding of software testing methodologies, tools, and best practices, with a preference for embedded software testing experience.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and collaboration skills.
  • Ability to work in a fast-paced, dynamic environment.
  • Automation experience.
  • Familiarity with DevOps practices and tools.
  • Knowledge of regulatory standards in the medical device industry.
  • Experience with products from prototype through 510(k)/ISO clearance and commercialization.
  • Familiarity with IEC 62304, ISO 14971, FDA regulations, and international standards for medical device software development, verification, and validation.
  • Base salary range of $64,500.00 - $96,750.00.
  • Hybrid working arrangements (requires on-site work from our Acton, MA office; may work remotely other days).
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