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Senior Software QA Engineer

Title: Senior Software QA Engineer

Location: Remote, US

About iRhythm:

iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable biosensing technology with powerful cloud-based data analytics and machine- learning capabilities. Our goal is to be the leading provider of first-line ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 6 million patients and their doctors on a shorter path to what they both need answers.

About this Role:

The iRhythm Software Quality Assurance and Test Engineering team is looking for a highly skilled Senior Software Quality Assurance Engineer with experience working in a regulated domain. In this role you will have the opportunity to support development and verification phases of medical device software and will play a crucial part in ensuring the quality, safety, and regulatory compliance of iRhythm software products as we expand into international markets. This position provides an opportunity to work with a talented team on a diverse, innovative set of SaaS based solutions within the medical device/software industry. We are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!

Location: Remote from a US based home office.

Please note we are unable to offer any sort of sponsorship for this role.

Responsibilities include:

  • Plan, develop, and execute comprehensive software quality assurance strategies and testing campaigns for SaMD and Non-Device MDDS that are part of international program releases with multi-language support.
  • Analyze software requirements and design inputs, develop test documentation deliverables (test cases, test plans, test reports, and traceability matrices) that comply with ISO 13485 and IEC 62304 standards.
  • Develop written verification test cases, subsequently document and report test results to both functional and customer requirements – in a manner consistent with regulatory and internal standards.
  • Identify software defects and track through resolution in the software development life cycle; provide test coverage for user stories.
  • Understand principles of design controls, risk management, and regulations applicable in medical device industry.
  • Work closely with Test Automation, Dev, Product, TPM, and RA/QA partners in scrum teams following agile methodology, participate in stand-ups, report status in project meetings.
  • Support software deployments in a variety of test, staging, and production environments.

About you:

  • Bachelor’s degree in a technical discipline such as Computer Science
  • 5+ years of Software QA experience
  • Detail-oriented mindset with commitment to maintaining the highest standards of quality.
  • Technical domain knowledge of localization and internationalization quality assurance processes and methodologies.
  • Working knowledge of AWS or other Cloud Platforms.
  • Proficiency with MySQL in Linux environment
  • Strong understanding of QA principles and processes in an FDA and International regulated environments (e.g. ISO 13485, IEC 62304)
  • Excellent analytical and problem-solving skills, finding creative solutions.
  • Great communication skills. Passion for teamwork, collaboration, and open communication.
  • Self-motivated with ability to work independently as well as to collaborate with other engineers.
  • Highly technical individual.
  • Previous experience testing medical devices and the related verification, validation, and documentation requirements a plus.
  • Previous experience with automated testing tools and frameworks a plus. Programming experience in one or more of the following languages: Java, Python, C/C++, and/or .NET/C#.

What’s in it for you:

This is a full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurance (all of which start on your first day), paid holidays, and PTO!

iRhythm also provides additional benefits including 401K (with company match), an Employee Stock Purchase Plan, paid parental leave, pet insurance discount, Cultural Committee/Charity events, and so much more!

FLSA Status: Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.

Make iRhythm your path forward.

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