> Markdown version of [/jobs/ext/1657811-design-quality-engineer-medical-devices](https://www.wearedevelopers.com/jobs/ext/1657811-design-quality-engineer-medical-devices). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Design Quality Engineer (Medical Devices) - **Company:** Inbrain Neuroelectronics - **Location:** Barcelona, Spain - **Contract:** Permanent contract - **Skills:** Computer-Aided Design, Data Analysis, Artificial Neural Networks, SolidWorks (CAD), Document Management Systems, Minitab, Software Engineering, JMP (Statistical Software), Statistics Packages - **Published:** July 17, 2026 - **Apply:** https://www.adzuna.es/contact-us.html ## About the Role + Bachelor's degree in engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical field. + Around 4-7 years of experience in design quality or product development roles within the medical device industry. + Fluent in English (both written and spoken) as it is the company language + Strong knowledge of ISO 13485, 21 CFR Part 820 (FDA QSR), MDR (EU 2017/745), and other applicable international regulations. + Familiarity with ISO 14971 (risk management), IEC 60601 (safety and performance), and IEC 62304 (software lifecycle processes). + Experience conducting internal audits, supplier audits, and managing external audits (FDA, notified bodies). + Proven ability to work with regulatory bodies to achieve product approvals (e.g., FDA 510(k)/PMA, EU CE marking). + Ability to lead cross-functional teams and manage product lifecycle from R&D to production. + Excellent organizational skills for tracking documentation, timelines, and deliverables. + Strong written and verbal communication for creating design documentation, risk assessments, and regulatory submissions. + Analytical mindset to identify design or process issues and implement effective corrective and preventive actions (CAPA). Nice to have: + A Master's degree is preferred, especially in fields related to medical devices or regulatory affairs. + Certified Quality Engineer (CQE) or Certified Biomedical Auditor (CBA) from ASQ. + Regulatory Affairs Certification (RAC) from RAPS. + Certified Six Sigma Green or Black Belt. + Direct experience with Class III active implantable devices (e.g., pacemakers, neurostimulators, drug delivery systems). + Demonstrated experience in supporting FDA premarket approval (PMA) or 510(k) submissions. + Knowledge of international market access requirements (e.g., EU MDR, Japan, Canada). + Understanding of design transfer processes and manufacturing quality assurance. + Experience with supplier quality management and production scale-up. + Familiarity with CAD (e.g., SolidWorks) and simulation tools for mechanical or electrical designs. + Experience using quality management systems (QMS) software. + Proficiency with statistical tools like Minitab or JMP for data analysis. + Proficiency in document control and electronic design history files (e.g., PLM software). We are looking for someone who Is ready to proactively bring new ideas to the team, push boundaries, and constantly look for innovation. At INBRAIN we believe in shared success and diverse ways of thinking, here you'll learn, grow, and advance in an innovative culture. ## Description We are scientists, doctors, techies and humanity lovers, with the mission of building neuroelectronic interfaces to cure brain disorders. INBRAIN harnesses the extraordinary material properties of Graphene, the world's thinnest and nobel-prize winning material, to build safe, uninvasive and highly efficient neural solutions. Our mission is to decode and modulate neural networks to improve people's lives. As a Design Quality Engineer at INBRAIN, you will be responsible ensuring compliance with the development activities with the necessary regulatory requirements, ensuring effectiveness of the QMS in the development projects and more. You will be at the forefront of bringing advanced healthcare solutions to market, making a tangible difference in people´s lives worldwide. Main responsibilities: + Establish and maintain the DHF by ensuring the execution of PRO-7. + Coordinate and support the development team on the execution of the PRO-7. + Support supplier audits for outsourced development and manufacturing activities during the development of the device. + Contribute to the effectiveness of the QMS by implementing the necessary processes related to the projects in scope. + Ensure successful design transfer to production by coordination of DHF-DMR and DHR for projects in scope. ## Related Videos - [The Neuroscience of Engineering Culture: Why Your Team’s Brains Are Crashing](https://www.wearedevelopers.com/videos/2049-the-neuroscience-of-engineering-culture-why-your-team-s-brains-are-crashing) - [XR Demystified: Separating Facts from Fiction in 2024](https://www.wearedevelopers.com/videos/1117-xr-demystified-separating-facts-from-fiction-in-2024) - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Google Gemma and Open Source AI Models - Clement Farabet](https://www.wearedevelopers.com/videos/1354-google-gemma-and-open-source-ai-models-clement-farabet) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [We Know Developers Are Neurodiverse. So Why Do Tech Teams Still Break?](https://www.wearedevelopers.com/videos/2023-we-know-developers-are-neurodiverse-so-why-do-tech-teams-still-break) ## Related Articles - [Are Brain-Computer Interfaces Good or Bad?](https://www.wearedevelopers.com/magazine/367-are-brain-computer-interfaces-good-or-bad) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [Top-Paying Tech Jobs (with Salaries)](https://www.wearedevelopers.com/magazine/372-top-paying-tech-jobs-with-salaries) - [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer) - [What Jobs Can You Get with a Software Engineering Degree?](https://www.wearedevelopers.com/magazine/398-what-jobs-can-you-get-with-a-software-engineering-degree)