Staff Design Quality Engineer

About this Role

A Staff 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 Staff 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.

The right candidate will have some experience within all areas of the Quality Management System, and expertise working with electromechanical devices, embedded systems, and software as medical device (SaMD).

This position is an onsite position and is based at our R&D Headquarters located in San Francisco, CA.

Specific job responsibilities include:

· 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.

· Applies statistical tools to analyze data and identify root cause and problem resolution.

· Perform other quality-related duties as assigned.

Required Qualifications:

· Bachelor’s degree in Computer Science, Software, Computer, Electrical, Mechanical or Biomedical Engineering.

· Minimum of 8 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, IEC 62304, and other international standards.

· Solid understanding of design control and risk management from early design and development through commercialization.

· Demonstrated experience with electromechanical system 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.

· Balanced risk-based decision making to drive product quality, gain consensus, and work through technical challenges.

· Experience using MasterControl, Jira, and JAMA is preferred.

· Solves complex problems with minimal oversight.

· Understands and can subsequently explain complex quality details to non-experts.

· Exceptional organizational skills.

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FLSA -Exempt