Senior Design Quality Engineer

Regulatory Toolkit; San Francisco (CA); Hybrid; USD 138,000 - 180,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Senior Design Quality Engineer in a hybrid role based in San Francisco or Cypress, CA.

You will support product development teams from concept through commercialization, providing hands-on engineering guidance on design control and risk management for class II/III medical devices with embedded software. The role requires deep knowledge of IEC 60601/62366/62304, plus experience with audits and regulatory interactions.

Qualifications

• Bachelor’s degree in Computer Science, Software, Computer, Electrical, Mechanical or Biomedical Engineering.
• Minimum of 5 years of QA experience for class II or III medical devices with embedded software.
• Demonstrated competency of 21 CFR 820, ISO13485, ISO14971 and other international standards.
• Solid understanding of design control and risk management from development through commercialization.
• Experience with electromechanical systems from concept through launch preferred.
• Proficiency with documentation, defect tracking and test management tools (e.g., Jira).

Responsibilities

• Contribute to design controls, risk management, and verification/validation.
• Support development of the design history file and ensure regulatory compliance.
• Define design inputs/outputs and traceability matrices with engineering.
• Lead risk-based design verification and validation strategies.
• Assist audits and regulatory interactions; prepare technical reports.

Skills

Quality Assurance

Design controls

Risk management

Audits

Education

Bachelor’s degree in Engineering

Tools

Jira

Master Control

JAMA

Job description

Career-defining. Life-changing.

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

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 in either San Francisco or Cypress, CA (Orange County) with a weekly onsite requirement of 2 days per week

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

Estimated Pay Range

$138,000.00 - $180,000.00

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 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.