Senior Design Quality Engineer – Medical Device (Hybrid SF)

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

Job summary

iRhythm Technologies is seeking a Senior Design Quality Engineer to support cross‑functional hardware, firmware, and software product development. You will drive design controls, risk management, and verification/validation from concept through commercialization in a hybrid role based in San Francisco.

The role requires 5+ years in medical device QA with embedded software, strong regulatory knowledge, and collaboration with engineering using tools like Jira.

Qualifications

• Bachelor’s degree in CS, software, EE, mechanical, or biomedical engineering.
• Minimum 5 years of QA for class II/III medical devices with embedded software.
• Strong knowledge of 21 CFR 820, ISO13485, ISO14971.
• Experience with design control and risk management from design to commercialization.
• Experience with electromechanical systems preferred.
• Proficient with documentation, defect tracking, and test management tools like Jira.

Responsibilities

• Contribute to design controls, risk management, and V&V for iRhythm products.
• Support DHF development and ensure compliance with standards.
• Define design inputs/outputs and traceability matrices with engineering.
• Lead risk assessments and validate changes and documentation.
• Assist audits and respond to audit findings.
• Produce technical reports for product changes and QA investigations.

Skills

Design controls

Risk management

Embedded software

Jira

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Computer Science/Electrical/Mechanical/Biomedical

Tools

MasterControl

JAMA

Job description

iRhythm Technologies is seeking a Senior Design Quality Engineer to support cross‑functional hardware, firmware, and software product development. You will drive design controls, risk management, and verification/validation from concept through commercialization in a hybrid role based in San Francisco.

The role requires 5+ years in medical device QA with embedded software, strong regulatory knowledge, and collaboration with engineering using tools like Jira.