Staff Design Quality Engineer
Staff Design Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Boldly innovating to create trusted solutions that detect predict and prevent disease.
Discover your power to innovate while making a difference in patients lives.iRhythm is advancing cardiac careJoin Us Now!
At iRhythm we are dedicated selfmotivated and driven to do the right thing for our patients clinicians and coworkers. Our leadership is focused and committed to iRhythms employees and the mission of the company. We are better together embrace change and help one another. We are Thinking Bigger and Moving Faster.
About this Role
A Staff Design Quality Engineer is responsible for supporting product development teams at iRhythm. In this role you will provide handson technical engineering support from concept through commercialization and postmarket evaluation. The Staff Design Quality Engineer serves as a core team member on crossfunctional hardware firmware standalone 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 iRhythms 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 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 of riskbased 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 qualityrelated duties as assigned.
Required Qualifications:
Bachelors 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 riskbased 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 nonexperts.
Exceptional organizational skills.
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FLSA Exempt
Actual compensation may vary depending on jobrelated factors including knowledge skills experience and work location.
As a part of our core values we ensure a diverse and 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
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect predict and prevent disease. Combining wearable biosensors and cloudbased data analytics with powerful proprietary algorithms iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care iRhythms 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.
Required Experience:
Staff IC
Employment Type
Full-Time
