---
title: 'Senior Quality Engineer at Epia Neuro'
canonical: 'https://feeny.ai/job/senior-quality-engineer-epia-neuro-alameda-z9sgaq9ss6zq'
type: 'job'
last_seen: '2026-09-07'
---

# Senior Quality Engineer at Epia Neuro

- **Company:** Epia Neuro
- **Location:** Alameda, CA
- **Compensation:** $115k–$150k
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-08-05
- **Last confirmed live:** 2026-09-07
- **Apply:** https://jobs.ashbyhq.com/epianeuro/a3c1ee76-f3d7-4d9e-a889-b68bf8073b7d

## 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.

## About Epia Neuro

## Company Overview
- **One-liner**: Epia Neuro is developing a minimally invasive, implantable brain-computer interface system that translates neural intent into real-world action, starting with stroke recovery and expanding to cognitive decline and other neurological disorders.
- **Entity Type**: Private (stealth-stage startup – officially launched April 2026; no funding round disclosed)
- **Headquarters**: Alameda, California, United States
- **Founded**: 2026 (official launch); development began approximately 2021
- **Founders**: Michel Maharbiz, Ph.D. (CEO) and Gil Mandelbaum, Ph.D. (CTO & Science Officer)

## Core Business
- **Primary industry**: Medical Equipment Manufacturing / Neurotechnology (Brain-Computer Interfaces)
- **Target customers**: B2B – hospitals, neurosurgery departments, rehabilitation clinics; B2C – stroke survivors and individuals with movement or cognitive impairments
- **Mission statement**: “To address the gap between intent and action” – building neurotechnology that gives back the freedom to move and think

## Products & Services
- **Implantable Brain Interface**: A proprietary neural interface that captures signals without piercing the dura. Designed for sub-hour implantation by any neurosurgeon. Supports both sensing (reading neural intent) and stimulation (closed-loop therapy). Rechargeable non-invasively via headset and built with a cradle system for future upgrades without additional invasive surgery.
- **Decoder System / Closed-Loop Intelligence**: Adaptive algorithms that interpret neural signals in real time and adjust stimulation parameters continuously, building a personalized “longitudinal map” of each patient’s neural activity.
- **Wearable Grip Assist**: A lightweight, daily-use motor prosthetic that helps stroke survivors grasp, hold, and release objects. Developed with input from survivors, advocates, and clinicians.
- **Platform Expansion**: The stroke therapy acts as a proof-of-concept for treating epilepsy, Parkinson’s disease, cognitive decline, and other neurological conditions through combined sensing and deep brain stimulation.

## Market Standing
- **Valuation**: Not publicly available (company is pre‑revenue and privately held)
- **Key Metric**: Total funding – not publicly disclosed (company is “totally independent” according to Inside BCI, with no disclosed investors)
- **Notable Investors/Partners**: Institutional advisors include Mass General Hospital, Lenox Hill Hospital (first‑in‑human trial site), Beth Israel Deaconess Medical Center, and Harvard Medical School. No formal investor list has been released.
- **Growth Signals**: Official launch April 2026; plans for first‑in‑human system demonstrations at Lenox Hill Hospital (New York) later in 2026; headcount of 24 employees (as of mid‑2026) with active hiring across engineering, electrical systems, and clinical roles; increasing LinkedIn follower base (1,459) and strong social engagement on launch posts.

## Competitive Advantages
- **Minimally Invasive**: Implant sits entirely within the skull, no breach of dura – reduces surgical risk compared to penetrating cortical BCIs.
- **Quick Procedure & Scalability**: Designed for sub‑hour implantation by any neurosurgeon, facilitating broad clinical adoption.
- **Upgradable & Long‑Life**: Cradle system allows device upgrades without additional surgery. Rechargeable headset eliminates the need for battery‑replacement surgeries.
- **Closed‑Loop Read/Write**: Both senses neural signals and delivers stimulation, enabling adaptive, real‑time therapy (beyond read‑only BCIs).
- **Platform Approach**: Stroke motor recovery is the entry point; the same hardware/software stack can address epilepsy, Parkinson’s, and cognitive decline, creating a large addressable market (estimated >$5B US opportunity for stroke alone).

## Strategic Focus
- **Near‑term**: Complete first‑in‑human demos, prepare for regulatory submissions (FDA), and scale the engineering team.
- **Medium‑term**: Leverage stroke clinical data to build evidence for cognitive decline and other indications; broaden the implant’s deep brain stimulation capabilities.
- **Long‑term**: Become a standard‑of‑care neural interface platform for a wide range of neurological disorders, with an emphasis on “widely accessible” neurotechnology.

## Why Work Here
- **Mission‑Driven**: Employees directly contribute to restoring independence for stroke survivors and people with neurological conditions (“If you want your work to restore independence for millions of people, we want to hear from you.”)
- **Cutting‑Edge Technology**: Work on the frontier of medical BCI, combining implantable hardware, adaptive AI, and real‑time neural decoding.
- **Early‑Stage Culture**: As a recently launched startup (~24 employees), you’ll have outsized impact on product design, clinical strategy, and company trajectory.
- **Multidisciplinary Team**: Composed of engineers, neuroscientists, and operations leaders from iota Biosciences, UC Berkeley, Harvard, and industry.
- **Work Style**: Likely in‑office in Alameda, CA (with a small presence in Canada); no formal remote/hybrid policy announced yet.
- **Active Hiring**: Open roles include Staff/Principal Electrical Systems Engineer, Analog Mixed‑Signal Design Engineer, and other technical positions (see careers page).

## Sources
1. [epianeuro.com](https://www.epianeuro.com/)
2. [businesswire.com](https://www.businesswire.com/news/home/20260402282679/en/Epia-Neuro-Launches-to-Develop-Intent-Driven-Neural-Technology-to-Restore-Function-After-Stroke-and-Address-Cognitive-Decline)
3. [linkedin.com/company/epia-neuro](https://www.linkedin.com/company/epia-neuro)
4. [insidebci.com](https://insidebci.com/news/2026-04-22-maharbiz-launches-epia-neuro-stroke-focused-bci-built-for-lifelong-assistive-use/)

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