Title: Senior Software Design Quality Engineer, Remote
Location: Remote, US
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 2 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 design assurance, compliance and technical support for the software development life cycle, design control, and risk management processes.
As a Sr. Software Design Quality Engineer, 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. In this dynamic environment you will have the opportunity to develop your technical skills and leadership competencies in the MedTech and wearable device industry while advancing your career.
Additionally, this role will also lead in the ongoing implementation of electronic Quality Management Systems (QMS) and Software Development Life Cycle (SDLC) processes, including Quality System software validations. This Software Quality Engineering role works in collaboration with engineering and product development teams, as well as the Quality System and IT teams at iRhythm.
- Execute System Validation of Software as a service (SaaS) tool for intended use, Data Integrity, Code of Federal Regulations (CFR) 21 Part 11 Compliance, Audit Preparation and Support, Data Migration, and Release and Change Management Process.
- Investigate validation discrepancies, drive deviation management, and create best-practices for system validation including Computer System Validation (CSV).
- Ensuring adherence to design control and risk management processes.
- 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.
- Bachelor’s degree in a technical discipline, with a minimum 5 years of software quality engineering experience in the medical device industry or equivalent.
- A dedication to assuring product quality and end-user satisfaction.
- 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, 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.