Design Quality Engineer Medical Devices
Design Quality Engineer Medical Devices
Posted on :
11-04-2025
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1 Vacancy
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Job Description
Your mission
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 worlds thinnest and nobelprize winning material to build safe uninvasive and highly efficient neural solutions. Our mission is to decode and modulate neural networks to improve peoples lives.
As aDesign 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 peoples lives worldwide.
Your profile
Main responsibilities:
- Establish and maintain the DHF by ensuring the of PRO7.
- Coordinate and support the development team on the of the PRO7.
- 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 DHFDMR and DHR for projects in scope.
Mandatory Qualifications and Soft skills:
- Bachelors degree in engineering Biomedical Engineering Electrical Engineering Mechanical Engineering or a related technical field.
- Around 47 yearsof experience indesign qualityorproduct development roles within themedical 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 crossfunctional 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 Masters 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 scaleup.
- 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).
Why us
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 youll 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. Youll be part of a team that strives to create meaningful change.
- CuttingEdge Technology Exposure: Joining us means immersing yourself in the latest technologies and innovative solutions. Youll have access to stateoftheart 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 were not just offering a job were inviting you to be part of a transformative journey Are you ready to transform lives Join us!
#diverseandinclusive
We believe that a diverse and wellbalanced 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.
About us
Learn more about us at INBRAIN
Employment Type
Full-Time
Key Skills
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