Sr Design Quality Engineer - Software at iRhythm

About iRhythm:

iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 3 million patients and their doctors on a shorter path to what they both need – answers.

About this role:

Responsible for Quality Engineering and compliance activities of AI based software development projects, providing hands-on quality assurance, compliance and technical support for the software development life cycle, design control, and risk management processes.

As a Sr. Design Quality Engineer in Software, you will be part of the Quality and Regulatory organization but will work closely with software engineering and data science teams to ensure that the design control objectives are met including the quality of Software as a Medical Device (SaMD) products released by iRhythm.  Although this role is not responsible for hands-on testing of the software product, this individual will work closely with the testing team members to ensure all internal and external requirements are met

As the Sr. Design Quality Engineer in Software you will have the opportunity to work closely with various areas of the organization, including iRhythm’s top team of software developers, software testers, data scientists, program and project managers, customer care, and user experience teams.  In this dynamic environment you will have the opportunity to develop your technical skills and leadership competencies and in this fast growing organization you will have the opportunity to advance your career.     

 Responsibilities include:                                                                        

• Ensuring adherence to design control and risk management processes. 
• Reviewing and approving test plans and test reports, and subsequently ensuring that test results are documented in a manner consistent with both internal and external quality and regulatory requirements.
• Reviewing software requirements and design documentation to ensure technical accuracy as well as testability; acting as a quality advocate throughout the software development cycle.
• Participating in software release coordination and deployment after appropriate verification.
• Ensuring that the Software team is following the software development lifecycle process as documented in the internal iRhythm’s procedures and in compliance with IEC 62304 and 21 CFR 820.30 for design controls.
• Serves as a Design Quality representative on one or more project teams engaged in new product development, business system implementations or other special projects.

Basic Qualifications

• Bachelor's degree in a technical discipline, with a minimum 5 years of software quality engineering experience in the medical device industry.
• A dedication to assuring product quality and end-user satisfaction.
• Strong written communication skills, given that detailed and accurate documentation is the key aspect of this position.
• Project experience working closely with a software development team as a software quality engineer.
• Excellent analytical and problem solving skills, and a proven ability to find creative solutions.
• Ability to work independently as well as to communicate and collaborate in cross-functional teams.

 Required Technical Qualifications

• Familiarity with the software quality engineering processes in the medical device industry and the related documentation requirements.
• Working knowledge of International Standard IEC 62304 – Medical device software – Software life cycle processes
• Additionally a working knowledge of the following Standards and Regulations is required
•  21 CFR 820.30 - Quality System Regulations (Design Controls Section)
• ISO 13485 – Quality Management Systems
• ISO 14971 – Application of the Risk Management Process for Medical Devices

What’s in it for you:

This is a full-time position with competitive compensation package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off.

iRhythm also provides additional benefits including 401K (w/ company match), employee stock purchase plan, annual organizational and cultural committee events and 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.