Senior Design Quality Engineer

About the 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, and stand-alone software product development projects and provides expertise and guidance to the team on design control and risk management. 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 per week in San Francisco.

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, ISO 13485, ISO 14971, 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.

Qualifications

• 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 MasterControl, Jira, and Jama is preferred.

Schedule

Hybrid role requiring 2 days per week onsite in San Francisco.

Pay

Estimated pay range: $138,000 – $180,000 per year. Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

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.