Senior Design Quality Engineer — MedTech Design Controls & Risk

Regulatory Jobs; San Francisco (CA); Ibrido; USD 138.000 - 180.000; Tempo pieno

Descrizione del lavoro

iRhythm Technologies, Inc. is seeking a Senior Design Quality Engineer in a hybrid role based in San Francisco or Cypress, CA.

You will support product development teams from concept through commercialization, providing hands-on engineering guidance on design control and risk management for class II/III medical devices with embedded software. The role requires deep knowledge of IEC 60601/62366/62304, plus experience with audits and regulatory interactions.

Competenze

• Bachelor’s degree in Computer Science, Software, Computer, Electrical, Mechanical or Biomedical Engineering.
• Minimum of 5 years of QA experience for class II or III medical devices with embedded software.
• Demonstrated competency of 21 CFR 820, ISO13485, ISO14971 and other international standards.
• Solid understanding of design control and risk management from development through commercialization.
• Experience with electromechanical systems from concept through launch preferred.
• Proficiency with documentation, defect tracking and test management tools (e.g., Jira).

Mansioni

• Contribute to design controls, risk management, and verification/validation.
• Support development of the design history file and ensure regulatory compliance.
• Define design inputs/outputs and traceability matrices with engineering.
• Lead risk-based design verification and validation strategies.
• Assist audits and regulatory interactions; prepare technical reports.

Conoscenze

Quality Assurance

Design controls

Risk management

Audits

Formazione

Bachelor’s degree in Engineering

Strumenti

Jira

Master Control

JAMA

Descrizione del lavoro

iRhythm Technologies, Inc. is seeking a Senior Design Quality Engineer in a hybrid role based in San Francisco or Cypress, CA.

You will support product development teams from concept through commercialization, providing hands-on engineering guidance on design control and risk management for class II/III medical devices with embedded software. The role requires deep knowledge of IEC 60601/62366/62304, plus experience with audits and regulatory interactions.