Design Quality Engineer (Medical Devices)

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.

Mandatory Qualifications and Soft skills:

• 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.


WHAT CAN WE OFFER TO YOU?

• A collaborative environment where innovative ideas flourish and teamwork drives us forward. At INBRAIN, we believe the power of collective intelligence is unique. You will be part of a team that thrives on open communication, knowledge sharing and mutual respect.
• Meaningful Work Impact: Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. You'll be part of a team that strives to create meaningful change.
• Cutting-Edge Technology Exposure: Joining us means immersing yourself in the latest technologies and innovative solutions. You'll have access to state-of-the-art tools and resources, fostering continuous learning and keeping your skills relevant in a rapidly evolving industry.
• Competitive salary (according to your experience/skills)
• Payflow & Flexflow
• Private Health Insurance
• Training bonus for professional development and access to Udemy platform
• 23 vacation days per year
• Christmas week off
• Hybrid working modality

Applications must be submitted in English

At INBRAIN, we're not just offering a job – we're inviting you to be part of a transformative journey, Are you ready to transform lives? Join us!

#diverseandinclusive
We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation, identity and diverse abilities or any other status.