Senior Design Quality Engineer - Hybrid (Medical Devices)

El Camino Health; Cypress (CA); Hybrid; USD 138,000 - 180,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Senior Design Quality Engineer to support product development through commercialization and post-market evaluation.

You will lead design controls, risk management, and verification/validation for cross-functional hardware, firmware, and software projects, with emphasis on medical device quality systems. This hybrid role requires a Bachelor's in engineering and 5+ years in QA for class II/III medical devices with embedded software, and practical knowledge

Qualifications

• Bachelor's degree in computer science, software, electrical, mechanical or biomedical engineering or related field.
• Minimum 5 years of QA experience in medical devices with embedded software.
• Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971 and related standards.
• Solid understanding of design controls and risk management from concept to commercialization.

Responsibilities

• Plan and execute design controls, risk management, and design verification/validation for iRhythm products.
• Contribute to risk management file development and regulatory compliance activities.
• Define design inputs/outputs and establish traceability matrices with engineering teams.
• Lead risk assessments and preventive strategies for QA processes.
• Support audits and regulatory inspections with preparation and direct interaction.

Skills

Jira

Quality assurance

Risk management

Design controls

Embedded software

Regulatory compliance

Education

Bachelor's degree in engineering or computer science

Tools

MasterControl

JAMA

Jira

Job description

iRhythm Technologies, Inc. is seeking a Senior Design Quality Engineer to support product development through commercialization and post-market evaluation.

You will lead design controls, risk management, and verification/validation for cross-functional hardware, firmware, and software projects, with emphasis on medical device quality systems. This hybrid role requires a Bachelor's in engineering and 5+ years in QA for class II/III medical devices with embedded software, and practical knowledge