Senior Quality Engineer

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

About Us

Epia Neuro is a neural technology company developing intent-driven systems designed to restore function and independence for people living with neurological conditions. Its platform integrates implantable neural interfaces, adaptive algorithms, and assistive devices to translate neural intent into real-world action. The company's initial focus is stroke-related motor impairment, with expansion in cognitive decline and other neurological disorders, focusing on long-term solutions for the growing aging population.

The Opportunity

We're building out our quality function from the ground up, and we're looking for a Senior Quality Engineer to help us do it. You'll bring hands-on software quality engineering experience to support our software and firmware teams in meeting IEC 62304, ISO 14971, and ISO 13485/FDA QMSR requirements throughout the product lifecycle.

Reporting to our Quality Manager, you'll contribute to design control reviews, help maintain the software risk management file, and support release and change control decisions. This is a role for someone who wants to help stand up a quality function early and grow into more independent authority as the function matures.

Key Responsibilities

• Foundational Quality Processes: Help build and document core software quality processes including design control procedures, traceability practices, and review workflows that will 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; working with software and firmware engineers, lead software safety classification based on risk.

• Configuration Management & Change Control: Support source control and build reproducibility audits against regulatory requirements; 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: Support quality review of ML model lifecycle documentation.

• Audits & CAPA: Support internal and FDA audits alongside our Quality Manager; contribute to root-cause analysis and CAPA for software defects.

Required Qualifications

• Bachelor's degree required, preferred 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 work with IEC 62304 lifecycle deliverables for Class C software.

• Working knowledge of ISO 13485 quality systems and design and development documentation.

• Experience contributing to risk management (ISO 14971) processes within the scope of medical device software.

• Comfortable raising quality concerns directly with engineering teams and holding a position under pressure while partnering constructively to help identify and define appropriate solutions.

Preferred Qualifications

• Experience with Class III or active implantable medical device products.

• Familiarity with usability engineering (IEC 62366) documentation for medical device software.

• Exposure to medical device cybersecurity documentation (FDA premarket expectations, SBOM).

• Familiarity with AI/ML in medical devices (Good Machine Learning Practice principles)

• Exposure to agile software development in a regulated context (AAMI TIR45).

• Previous role at a fast-paced medical device startup.

How We Work

• We are intentional. We prioritize and are thoughtful about how we use others' time.

• We care for others. We prioritize safety both for patients and one another.

• We own outcomes, not just tasks. Our work demands the highest standards because it impacts real patients and real lives.

• Humility is a strength. We are honest about what we know and what we don't know. Getting it right matters more than being right.

Benefits

Full-time employees are eligible for the following benefits:

• Competitive base salary with equity

• 100% of healthcare coverage for you and your dependents

• Generous vacation policy

• Paid parental leave

• Work from our beautiful waterfront office in Alameda, CA, with access to collaborative spaces and labs.