Boldly innovating to create trusted solutions that detect, predict, and prevent disease.
Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care…Join Us Now!
At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm’s employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.
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 immigration 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 regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer:
- Emotional health support for you and your loved ones
- Legal / financial / identity theft/ pet and child referral assistance
- Paid parental leave, paid holidays, travel assistance for personal trips and PTO!
- Wellness/ cultural committee/charity events
iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes, and so much more!
FLSA Status:Exempt
#LI-AR1
#LI-Remote
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
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. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.
Make iRhythm your path forward. Zio, the heart monitor that changed the game.