Senior Design Quality Engineer - Medical Devices, Impact

iRhythm Technologies, Inc.; Anaheim (CA); Hybrid; USD 138,000 - 180,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Senior Design Quality Engineer to support cross-functional hardware, firmware, and software product development from concept through commercialization and post-market evaluation.

You will ensure compliance with IEC 60601, IEC 62366, and IEC 62304, lead design controls, risk management, and design verification/validation activities, and collaborate with engineering to define inputs/outputs and maintain traceability.

Qualifications

• Bachelor's degree in engineering or computer science.
• Minimum 5 years in QA of class II/III medical devices with embedded software.
• Experience with 21 CFR 820, ISO13485, ISO14971 and related standards.
• Strong design controls and risk management from concept to commercialization.
• Experience with electromechanical systems from concept through launch preferred.
• Proficiency with Jira or similar defect tracking tools.

Responsibilities

• Plan and execute design controls and risk management for iRhythm products.
• Develop and maintain design history files and ensure regulatory compliance.
• Define design inputs/outputs and maintain traceability matrices with engineering.
• Lead risk-based design verification and validation activities.
• Support risk management file development addressing product risks.
• Review design architectures and requirements early in concept.
• Assist audits and prepare technical reports.
• Support internal and external audits.

Skills

Design controls

Risk management

Verification & validation

Regulatory compliance

Jira

Embedded software

IEC standards

Education

Bachelor's degree in engineering or computer science

Tools

MasterControl

Jira

JAMA

Test management tools

Job description

iRhythm Technologies, Inc. is seeking a Senior Design Quality Engineer to support cross-functional hardware, firmware, and software product development from concept through commercialization and post-market evaluation.

You will ensure compliance with IEC 60601, IEC 62366, and IEC 62304, lead design controls, risk management, and design verification/validation activities, and collaborate with engineering to define inputs/outputs and maintain traceability.