Quality Assurance Engineer
OuraFull Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Candidates must possess a Bachelor's degree in a technical discipline and over 10 years of software QA experience, including at least 3 years in medical device or FDA-regulated software development. A proven track record of leading verification test efforts for medium to large projects, demonstrated ownership of DHF deliverables, and a strong understanding of design control procedures and the software development lifecycle in regulated environments are essential. Experience supporting regulatory submissions and audits, excellent analytical and problem-solving skills, and the ability to work independently are required. Proven ability to mentor junior QA team members, effective written and verbal communication skills with strong attention to detail, and hands-on experience with MySQL, Linux, and Agile environments are necessary. The ability to quickly learn new tools, applications, and technologies, and to act as a quality advocate within cross-functional teams is also required. Familiarity with ISO 14971 and IEC 62304, along with experience in regression test automation, are considered a plus.
The Senior Software QA Engineer II will own and lead the design and execution of verification strategies, including test plans, protocols, reports, and traceability matrices, in compliance with FDA, IEC 62304, and ISO 13485 requirements. They will provide input to verification time and resource estimates, report project status, and track test metrics, while working on multiple projects and meeting deadlines. Responsibilities include reviewing and contributing to requirements and design documentation, providing cross-functional support for new product introductions and software releases, and preparing SQA documentation for regulatory submissions. The role involves defining test strategies and effort estimates based on risk and project scope, working with databases, APIs, and Linux environments to validate data integrity, system behavior, and workflow accuracy, and supporting end-to-end integration testing of clinical software. Analyzing and testing production issues, driving root cause investigations, and determining regression test scope are key duties. The engineer will collaborate daily with development, product, TPM, and QE partners in Agile teams, participate in stand-ups, sprint planning, and project status meetings, and contribute to DHF activities. Mentoring junior QA engineers and championing quality best practices across Agile teams are also part of the role, along with partnering with test automation engineers to identify and implement automation opportunities.
Advanced cardiac monitoring solutions provider
iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.