Insulet Corporation-posted 3 months ago
$94,725 - $142,087/Yr
Full-time • Senior
Hybrid • Acton, MA
Miscellaneous Manufacturing

Insulet is looking for a self-motivated Senior 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.

  • Lead the validation efforts for non-product custom tools used within the Pod Software Group.
  • Develop and execute comprehensive test plans, test cases, and test scripts.
  • Collaborate with cross-functional teams, including software development, DevOps, Automation, and product management, to ensure tool quality and functionality.
  • Identify, document, and track defects, and work with development teams to resolve issues.
  • Ensure compliance with regulatory standards and company policies.
  • Provide mentorship and guidance to junior SQA team members.
  • Continuously improve testing processes and methodologies.
  • Self-Motivated
  • Proactive
  • Quick Learner
  • Strong understanding of the Software Development Life Cycle (SDLC) and quality assurance methodologies.
  • Proficiency in manual testing tools and approaches.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and collaboration skills.
  • Thorough understanding of software quality assurance principles, practices, and metrics, as well as software development and testing best practices that foster high-quality software.
  • Hands-on experience using modern software development and quality assurance tools.
  • Proven record of developing and executing software test protocols for complex medical devices.
  • Automation experience
  • Experience with DevOps practices and tools
  • Knowledge of regulatory standards in the medical device industry
  • Experience working with products from prototype through 510(k)/ISO clearance and commercialization
  • Familiarity with IEC 62304, ISO 14971, FDA regulations, and international standards applicable to medical device software development, verification, and validation
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