Staff Design Quality Engineer
Description For Staff Design Quality Engineer
iRhythm Technologies is at the forefront of revolutionizing cardiac health through innovative digital healthcare solutions. As a Staff Design Quality Engineer, you'll play a crucial role in ensuring the quality and regulatory compliance of their medical devices and software products. The position offers a unique blend of technical engineering and quality assurance, focusing on embedded systems and software as medical device (SaMD).
The role requires a strong background in quality assurance within the medical device field, particularly with class II or III products. You'll be working with cross-functional teams, contributing to product development from concept through commercialization. The position demands expertise in design control, risk management, and various international standards including IEC 60601, IEC 62366, and IEC 62304.
This hybrid role, requiring at least 2 days per week onsite, offers competitive compensation ($135,000 - $175,000) and comprehensive benefits. The company provides an excellent environment for professional growth, with opportunities to impact global healthcare outcomes. You'll be part of a team that values innovation, quality, and patient care, working on products that directly affect people's lives.
iRhythm's culture emphasizes collaboration, continuous learning, and professional development. The company offers various learning resources, including unlimited LinkedIn Learning classes, and promotes a balanced approach to work with flexible benefits and strong support for work-life balance. Their mission of advancing cardiac care through technology makes this an ideal position for someone passionate about healthcare innovation and quality engineering.
The role offers significant growth potential within a rapidly expanding company, making it an excellent opportunity for experienced quality engineers looking to make a meaningful impact in healthcare technology while advancing their careers.
Responsibilities For Staff Design Quality Engineer
- Contribute to planning and execution of design controls, risk management, and design verification and validation
- Participate in development of product design history file
- Partner with engineering to define design inputs, outputs, and traceability matrices
- Contribute to strategy and execution of risk-based design verification and validation
- Review design architectures, selections, requirements, and drawings
- Apply knowledge of IEC standards to product development projects
- Perform and lead risk assessments
- Assist technical teams in assessment of design changes
- Produce technical reports
- Support internal and external audits
Requirements For Staff Design Quality Engineer
- 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 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
- Experience with electromechanical systems
- Proficiency in using tools for documentation, defect tracking, and test management
- Experience using Master Control, Jira, and JAMA preferred
Benefits For Staff Design Quality Engineer
- Medical insurance
- Dental insurance
- Vision insurance
- Health savings account
- 401(k) with company match
- Employee Stock Purchase Plan
- Paid parental leave
- Paid holidays
- PTO
- Life insurance
- Short/long term disability
- Commuter benefits
- Pet insurance discount
- LinkedIn Learning access
Jobs Related To iRhythm Technologies Staff Design Quality Engineer
