Senior Medical Device Quality Engineer - ISO 13485/IEC 62304

Epia Neuro; Alameda (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive base salary with equity

100% healthcare coverage

Generous vacation policy

Paid parental leave

Office in Alameda, CA with labs and a艇

Job summary

Epia Neuro is seeking a Senior Quality Engineer to help build out the quality function for medical device software and firmware. You will support IEC 62304, ISO 14971, ISO 13485/FDA QMSR compliance throughout the product lifecycle and collaborate with software teams on risk management and design controls.

You will report to the Quality Manager and help stand up robust change control, document review workflows, and audit readiness while growing into more independent authority as the function

Qualifications

• Bachelor's degree in a related field such as Biomedical Engineering, Computer Science/Software Engineering, Electrical Engineering, Systems Engineering, Quality Engineering, or Industrial Engineering.
• 5+ years of experience in medical device software quality engineering, including hands-on IEC 62304 lifecycle deliverables for Class C software.
• Working knowledge of ISO 13485 quality systems and design and development documentation.
• Experience contributing to ISO 14971 risk management processes within the scope of medical device software.
• Ability to raise quality concerns directly with engineering teams and work under pressure to define effective solutions.

Responsibilities

• Foundational Quality Processes: Build and document core software quality processes including design control procedures, traceability practices, and review workflows that scale with the company.
• Design Controls & Risk Management: Contribute to design input/output reviews and verification/validation activities under ISO 13485/FDA QMSR; maintain the software contribution to the ISO 14971 risk management file, including hazard-to-requirement traceability.
• IEC 62304 Compliance: Review software development plans, lifecycle deliverables, and verification documentation against IEC 62304; lead software safety classification with software/firmware engineers based on risk.
• Configuration Management & Change Control: Support source control and build reproducibility audits; assess engineering change requests for software safety, risk, and regulatory impact.
• SOUP & Cybersecurity: Own evaluation and qualification of third-party software, libraries, and vendors (SOUP); review premarket cybersecurity documentation for completeness.
• AI/ML Quality Support: Assist quality review of ML model lifecycle documentation.
• Audits & CAPA: Support internal and FDA audits; contribute to root-cause analysis and CAPA for software defects.

Skills

IEC 62304

ISO 13485

ISO 14971

Regulatory compliance

Software quality engineering

Education

Bachelor's degree

Job description

Epia Neuro is seeking a Senior Quality Engineer to help build out the quality function for medical device software and firmware. You will support IEC 62304, ISO 14971, ISO 13485/FDA QMSR compliance throughout the product lifecycle and collaborate with software teams on risk management and design controls.

You will report to the Quality Manager and help stand up robust change control, document review workflows, and audit readiness while growing into more independent authority as the function