Senior Design Quality Engineer

Senior Design Quality Engineer supporting medical device product development from concept through commercialization. Responsible for design control, risk management, and regulatory compliance for hardware, firmware, and software products in a hybrid San Francisco role.

Responsibilities

• Plan and execute design controls, risk management, and design verification and validation activities
• Develop and maintain product design history files ensuring compliance with internal processes and regulatory standards
• Partner with engineering teams to define design inputs, outputs, and traceability matrices
• Lead risk assessments and evaluate design changes including verification, validation, and documentation
• Support internal and external audits and produce technical reports for quality investigations

Requirements

• Bachelor's degree in Computer Science, Software, Electrical, Mechanical, or Biomedical Engineering
• Minimum 5 years quality assurance experience with Class II or III medical devices containing embedded software
• Demonstrated competency in 21 CFR 820, ISO 13485, and ISO 14971 standards
• Strong understanding of design control and risk management throughout product lifecycle
• Proficiency with documentation, defect tracking, and test management tools such as Jira
• Knowledge of IEC 60601, IEC 62366, and IEC 62304 standards
• Ability to work independently with minimal oversight on quality system processes

Compensation: $138,000-$180,000