Senior / Principal Software Quality Assurance Engineer

Posted on 5/1/2024

Fractyl Health, Inc

Fractyl Health, Inc

51-200 employees

Develops therapies for type 2 diabetes management



Burlington, MA, USA

Required Skills
Software Testing
Quality Assurance (QA)
  • Bachelor’s or Master’s degree in Computer Science, Engineering, or related field.
  • Certification in software quality assurance (e.g., ISTQB) or related fields is a plus.
  • Minimum of 7+ years of experience in software quality assurance, with at least 3 years in a senior or lead role.
  • Strong expertise in designing, implementing, and executing software test strategies and methodologies in a regulated environment (e.g., medical devices, healthcare, pharmaceuticals).
  • Experience with software validation, verification, and compliance with FDA regulations (e.g., 21 CFR Part 820, Part 11) and international standards (e.g., ISO 13485, IEC 62304).
  • Applicable experience in biotech, pharmaceutical and/or medical device industries preferred.
  • Experience utilizing requirements management tools (e.g., Helix, Doors, Jama)
  • Proficiency in automated testing tools and frameworks (e.g., Selenium, Appium, JUnit) and experience with test automation scripting (e.g., Python, Java).
  • Solid understanding of software development lifecycle (SDLC) processes, including Agile methodologies (e.g., Scrum, Kanban).
  • Excellent analytical, problem-solving, and troubleshooting skills, with a meticulous attention to detail.
  • Develop and implement comprehensive software test plans, test cases, and test scripts based on product requirements and design specifications.
  • Participate/consult in requirements definition process.
  • Lead software verification strategy and planning, and author verification and validation plans.
  • Conduct functional, regression, integration, and performance testing of software and firmware to identify defects and ensure adherence to quality standards.
  • Design, configure, and maintain automated testing frameworks and tools to streamline the testing process and increase test coverage.
  • Collaborate with software developers, systems engineers and regulatory affairs to identify quality risks, establish acceptance criteria, and mitigate potential issues.
  • Perform root cause analysis of software defects and work closely with development teams to resolve issues in a timely manner.
  • Participate in design reviews, risk assessments, and validation activities to ensure compliance with regulatory requirements (e.g., FDA, ISO 13485).
  • Document test results, track defects, and generate test reports to communicate findings and facilitate decision-making processes.
  • Drive continuous process improvement and implement QMS updates, participating in internal and external audits as required.
  • Mentor and provide guidance to junior QA team members, promoting best practices in software testing and quality assurance.
  • Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
  • Bring a “can do” spirit to work and deliver on other responsibilities as assigned.

Fractyl Health is pioneering Revita, an endoscopic procedural therapy that targets the root causes of type 2 diabetes by remodeling the duodenal lining via hydrothermal ablation. They are also developing Rejuva, a novel pancreatic gene therapy platform aimed at restoring insulin production and islet function in patients with advanced type 2 diabetes.

Company Stage


Total Funding



Lexington, Massachusetts



Growth & Insights

6 month growth


1 year growth


2 year growth