About us
We are a Belgian engineering consulting firm that assists SMEs and large industrial organizations in bringing their innovation and R&D initiatives to life.
Job Description
The Design Quality Engineer (DQE) plays a pivotal role within the R&D organization, driving the transition from general product development to full compliance with medical device standards. Reporting to the PMO Lead, this position is critical in ensuring that upcoming projects—such as Nexxis 2.0, SAI display, Nexxis Compute, and MCC-300—adhere to rigorous regulatory frameworks, including ISO 13485, 510(k), IEC 62304, risk management, usability, and clinical evaluation requirements. Beyond contributing directly to the creation of technical documentation, the DQE will also serve as a key enabler, guiding and strengthening the R&D team's capabilities in medical device development.
Key responsibilities
Technical File Ownership:
Build, maintain, and review technical files in collaboration with project managers.
Integrate inputs from product management, software architecture, security, and V&V teams.
Ensure complete documentation with risk, usability, and clinical evaluation teams.
Cross-Functional Enablement:
Act as liaison between R&D and QARA to clarify roles and responsibilities.
Coach teams on regulatory standards (e.g., IEC 62304) and best practices.
Align stakeholder contributions with compliance expectations.
Process & Quality Improvement:
Mentor teams on medical device standards and documentation quality.
Identify process gaps and drive improvements in compliance and file quality.
Foster a culture of continuous improvement in documentation practices.
Additional Contributions:
Develop regulatory strategies for global compliance.
Support internal and external audit readiness.
Deliver training on regulatory requirements and quality standards.
Ensure clear communication across all stakeholders.
Required qualifications
- Solid experience in medical device technical file development.
- Strong knowledge of ISO 13485, 510(k), IEC 62304, risk management, usability, and clinical evaluation.
- Excellent communication and facilitation skills.
- Proven ability to coach cross-functional teams.
- Analytical mindset with attention to detail and process improvement focus.
- 6 years of experience as a design quality engineer
Benefits
We offer you a position as a consultant within the fascinating world of high tech and innovation. We provide a complete package with on one side training, coaching and a close follow-up, and on the other side a balanced salary package with fringe benefits based on your capabilities and experience.
Working with us means choosing a long-term perspective, development possibilities, and a personal approach. A human-centered, diverse company that values and supports your physical and mental well-being.
