R&D Engineer

Freelance R&D Engineer - Class III Diagnostic Imaging Systems
Groningen, Netherlands | 🗓 Start: Early August | ⏱ 12-Month Contract | 40 Hours/Week
Hybrid Model: 3 Days On-Site / 2 Days Remote

Join a high-performing R&D team developing cutting-edge Class III diagnostic imaging technologies. This freelance assignment offers an opportunity to contribute to full-lifecycle design engineering on mission-critical systems regulated under MDR.

Scope of Work:
You will support technical development of advanced diagnostic platforms, collaborating with multi-disciplinary teams across hardware, software, and compliance to bring complex medical imaging products closer to commercial readiness.

Key Responsibilities:

• Lead detailed design and development activities under ISO 13485 and IEC 60601 standards
• Support engineering documentation required for MDR and Technical Dossier submission
• Participate in design input/output refinement, risk management (ISO 14971), and usability engineering (IEC 62366)
• Execute verification and validation protocols including bench testing, simulation, and design reviews
• Interface with quality, manufacturing, and clinical teams to ensure design for manufacturability, reliability, and clinical relevance
• Contribute to DHF (Design History File) maintenance and ensure traceability across engineering outputs
• Apply DFMEA methodology to proactively identify design risks and mitigation paths
• Support integration activities for electromechanical subsystems within imaging modalities

Profile Requirements:

• Demonstrated experience in Class III medical device R&D, ideally in diagnostic imaging or electromechanical platforms
• Strong familiarity with EU MDR, ISO 13485, IEC 60601, and related quality frameworks
• Ability to interpret and apply design control principles across the development lifecycle
• Skilled in technical documentation for regulatory submission and external audits
• Proficient in CAD tools and engineering change control workflows
• Right to work in the Netherlands is mandatory (no sponsorship)
• Available to commence project in early August