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About the Role

A Senior Design Quality Engineer supports product development teams, providing technical engineering support from concept through commercialization and post-market evaluation. This role serves as a core team member on cross-functional hardware, firmware, and software product development projects, offering expertise in design control and risk management to ensure products meet quality standards and regulatory requirements.

Responsibilities

Contribute to the planning and execution of design controls, risk management, and design verification and validation for iRhythm products.
Participate and support the development of product design history file and ensure compliance to internal processes and external standards and regulations.
Partner with engineering to define design inputs, design outputs, and traceability matrices.
Contribute to the strategy and execution of risk-based design verification and validation.
Participate and support the development of product risk management file, to examine and assess the product risks associated with user, design, process, and supplier.
Review design architectures, selections, requirements, and drawings from early design concepts.
Apply knowledge of IEC 60601, IEC 62366, and IEC 62304 to product development projects.
Serve as a technical resource for assessing validation requirements, solving test-related problems, and developing preventive strategies.
Perform and lead risk assessments in support of verification and validation activities.
Assist technical teams in the assessment of design changes; including assessment, planning, verification and validation of the change and documentation as required.
Produce technical reports to support product changes or quality assurance investigations.
Support internal and external audits, including preparation and direct interaction with auditors.
Perform other quality-related duties as assigned.

Requirements

Bachelor’s degree in Computer Science, Software, Computer, Electrical, Mechanical or Biomedical Engineering.
Minimum of 5 years of experience in Quality Assurance of class II or III products with embedded software in the medical device field.
Demonstrated competency of 21 CFR 820, ISO13485, ISO14971 and other international standards.
Solid understanding of design control and risk management from early design and development through commercialization.
Demonstrated experience with electromechanical systems from concept through launch is preferred.
Proficiency in using tools for documentation, defect tracking, and test management (e.g., Jira).
Able to navigate the quality system with minimal oversight on projects.

Skills

IEC 60601
IEC 62366
IEC 62304
Jira
Master Control
JAMA

Location

San Francisco

Work Type

Hybrid
Onsite

Experience Level

Senior

Education Level

Bachelor’s degree

Salary/Compensations

$138,000.00 - $180,000.00

About the Company

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.

Equal Opportunity

As a part of our core values, we ensure an 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.