Reports to: Senior Manager, Quality Assurance Engineering

Position Summary

Fractyl Health is seeking a highly skilled and experienced Senior/Principal Software Quality Assurance Engineer to join our team. The Senior/Principal QA Engineer will play a critical role in ensuring the quality and reliability of our software products, which are integral components of our medical devices. This individual will collaborate closely with cross-functional teams to develop and execute comprehensive testing strategies, maintain regulatory compliance, and drive continuous improvement in our software development processes. This role is expected to be a leadership role; the individual will have autonomy and provide mentorship and guidance to junior team members as well as external contractors. 

Primary Responsibilities

• 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.

Education or Certification Requirements

• 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.

Professional Work Experience

• 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.
• Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).

Qualifications and Skills

• 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.

Other Essentials and Key Success Factors

• Successful track record of working in high-growth and dynamic organizations
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
• Evidence of "hands-on" experience and expertise
• Proven and successful track record as a team-player and collaborator in small working environments
• Highly organized and detail oriented with a passion to deliver quality results
• Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
• Highest levels of professionalism, confidence, personal values and ethical standards

Travel

This position requires no regular travel.

The description and requirements outlined above are general; additional requirements may apply.