Senior Design Quality Engineer

El Camino Health; San Francisco (CA); On-site; USD 138,000 - 180,000; Full time

Job summary

iRhythm Technologies is seeking a Senior Design Quality Engineer to support cross‑functional hardware, firmware, and software product development. You will drive design controls, risk management, and verification/validation from concept through commercialization in a hybrid role based in San Francisco.

The role requires 5+ years in medical device QA with embedded software, strong regulatory knowledge, and collaboration with engineering using tools like Jira.

Qualifications

• Bachelor’s degree in CS, software, EE, mechanical, or biomedical engineering.
• Minimum 5 years of QA for class II/III medical devices with embedded software.
• Strong knowledge of 21 CFR 820, ISO13485, ISO14971.
• Experience with design control and risk management from design to commercialization.
• Experience with electromechanical systems preferred.
• Proficient with documentation, defect tracking, and test management tools like Jira.

Responsibilities

• Contribute to design controls, risk management, and V&V for iRhythm products.
• Support DHF development and ensure compliance with standards.
• Define design inputs/outputs and traceability matrices with engineering.
• Lead risk assessments and validate changes and documentation.
• Assist audits and respond to audit findings.
• Produce technical reports for product changes and QA investigations.

Skills

Design controls

Risk management

Embedded software

Jira

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Computer Science/Electrical/Mechanical/Biomedical

Tools

MasterControl

JAMA

Job description

About This Role

A Senior Design Quality Engineer is responsible for supporting product development teams at iRhythm. In this role you will provide hands‑on technical engineering support from concept through commercialization and post‑market evaluation. The Senior Design Quality Engineer serves as a core team member on cross‑functional hardware, firmware, stand‑alone software product development projects and provide expertise and guidance to the team on design control and risk management. In this position, you will play a key role in ensuring that products meet quality standards consistent with iRhythm’s quality processes, and all external design control and regulatory requirements. This position is hybrid with a weekly onsite requirement of 2 days/week in San Francisco.

What you’ll be doing

• 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.

What We Need To See

• 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.

Ways to Stand Out

Understands and can subsequently explain complex quality details to non-experts. Exceptional organizational skills. Solves complex problems with minimal oversight. Balanced risk-based decision making to drive product quality, gain consensus, and work through technical challenges. Demonstrated competency of IEC 62304, and other international standards. Experience using Master Control, Jira, and JAMA is preferred.

Location: San Francisco

Actual compensation may vary depending on job‑related factors including knowledge, skills, experience, and work location. Estimated Pay Range $138,000.00 - $180,000.00

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 [e-mail].

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.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. Together, we are reimagining the way cardiac arrhythmias are diagnosed. We need curious problem solvers like you. With opportunities remotely, at our office, in manufacturing, and in locations across the globe, this is your chance to meaningfully shape the future of cardiac health, our company, and your career.

Driven By Purpose - Cardiac health touches the lives of people all around us. Providing life‑changing healthcare solutions that impact patients around the world drives us to bring our best every single day.

Growth Means Opportunity - We are growing rapidly. And with that growth comes a wealth of opportunities to learn and advance at iRhythm. The potential to deepen your impact, seek new opportunities, and advance your career is yours to pursue.

Build the Future - We are a boundary‑pushing organization that values innovative thinking and impacts healthcare at a global level. The expectation is to think big and build the future you see for iRhythm, our patients, and yourself.