Process Development engineer - Netherlands
Process Development Engineer
Contract Type: 12-Month Freelance Contract
Industry: Medical Devices
Location: Utrecht, Netherlands (Hybrid: 4 days on-site, 1 day remote)]
We are seeking an experienced Process Development Engineer to join on a 12-month freelance basis. This role is critical to supporting process development and compliance within the medical device industry, ensuring adherence to regulatory standards and quality requirements.
Key Responsibilities
Process Design & Optimization:
- Develop and implement robust manufacturing processes for medical devices.
- Optimize existing processes for efficiency, scalability, and cost-effectiveness.
Validation & Documentation:
- Lead IQ/OQ/PQ validation activities for equipment and processes.
- Prepare and maintain technical documentation in compliance with MDR and ISO 13485 standards.
Regulatory & Quality Compliance:
- Ensure all processes meet EU MDR, ISO 13485, and relevant regulatory requirements.
- Support audits and inspections by providing accurate process documentation.
Technical Support & Troubleshooting:
- Investigate and resolve process-related issues using root cause analysis tools (e.g., FMEA, Fishbone diagrams).
- Collaborate with R&D, Quality, and Manufacturing teams to implement corrective actions.
Continuous Improvement:
- Apply Lean Manufacturing and Six Sigma methodologies to drive process improvements.
- Identify opportunities for automation and digitalization in production workflows.
Required Skills & Experience
- Strong background in process development within the medical device industry.
- In-depth knowledge of MDR, ISO 13485, and GMP requirements.
- Hands-on experience with validation protocols (IQ/OQ/PQ) and risk management tools (FMEA).
- Familiarity with CAD tools, statistical analysis software (Minitab, JMP), and DOE (Design of Experiments).
- Understanding of materials science, sterilization processes, and cleanroom standards.
- Excellent problem-solving and communication skills.
- Right to work in the Netherlands (mandatory).
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