Quality Systems Engineer (Medical Devices)

Location: San Francisco, United States; on-site

Company

hirify.global develops non-invasive, ultrasound-based technology for high-resolution brain stimulation and imaging, integrating hardware, software, and research capabilities.

What you will do

• Ensure product designs and processes meet internal and regulatory safety and performance requirements.
• Lead quality-critical discussions during new product development and influence design-control, investigational-study, and clinical-trial decisions.
• Manage multiple quality tasks and drive execution of change orders.
• Lead investigations and implement mitigations for CAPAs and non-conformances.
• Work with interdisciplinary teams to identify quality gaps and maintain rigorous standards.

Requirements

• At least 2 years of industry experience in quality systems engineering.
• Experience with design controls, product and process validation, and risk management.
• Degree in engineering or a scientific discipline, such as biomedical engineering, electrical engineering, or neuroscience, or equivalent hands-on experience.
• Familiarity with GCP and human factors.
• Familiarity with FDA QMSR, ISO 13485, ISO 14971, and FMEA-based risk management.
• Strong technical writing skills, integrity, and professional judgment.

Culture & Benefits

• Work with interdisciplinary engineering, software, hardware, and research teams.
• High standards for rigor, integrity, and execution.
• Contribute to technology intended to improve people's lives and benefit millions of users.