Senior Design Quality Engineer – Medical Devices (Hybrid SF)

iRhythm Technologies, Inc.; San Francisco (CA); Híbrido; USD 138.000 - 180.000; Jornada completa

Descripción de la vacante

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

You will lead design controls, risk management, and verification/validation activities to ensure products meet quality standards and regulatory requirements. This role requires hands‑on expertise in IEC 60601/62366/62304, ISO 13485, and 21 CFR 820, with collaboration across engineering to deliver safe,

Formación

• Bachelor’s degree in Engineering or related field; medical device exp preferred.
• 5+ years QA experience on class II/III devices with embedded software.
• Solid understanding of 21 CFR 820, ISO 13485, ISO 14971 and related standards.

Responsabilidades

• Support design controls, risk management, and verification/validation for iRhythm products.
• Develop and maintain design history files and ensure compliance with internal/external standards.
• Define design inputs/outputs and traceability with engineering teams.
• Lead risk assessments and preventive strategies in development.
• Prepare technical reports for changes and QA investigations.
• Assist audits and interaction with auditors.

Conocimientos

Quality assurance

Embedded software

Design control

Risk management

Medical devices

Educación

Bachelor's degree engineering

Biomedical/Electrical/Software engineering

Herramientas

Jira

MasterControl

JAMA

Descripción del empleo

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

You will lead design controls, risk management, and verification/validation activities to ensure products meet quality standards and regulatory requirements. This role requires hands‑on expertise in IEC 60601/62366/62304, ISO 13485, and 21 CFR 820, with collaboration across engineering to deliver safe,