epianeuro · Alameda HQ ·
Senior Quality Engineer builds and enforces medical-device software quality processes (IEC 62304, ISO 13485, ISO 14971) for a neural-interface startup, reviewing design controls, risk files, and AI/ML lifecycle documentation.
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.
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.
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.
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.
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.
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.
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.