Senior Design Quality Engineer
About The Position
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.
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, 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
Nice To Haves
- 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.
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.
Benefits
- Estimated Pay Range $138,000.00 - $180,000.00
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What This Job Offers
Job Type
Full-time
Career Level
Senior
