Manufacturing Engineer
Job Title: Freelance Manufacturing Engineer - Medical Devices
Location: Poland (Remote/On-site as required)
Contract Type: Freelance / Contract
Industry: Medical Devices / Manufacturing / Engineering
About the Role:
We are looking for a highly skilled Freelance Manufacturing Engineer with experience in the medical devices sector. This role involves supporting production optimisation, ensuring regulatory compliance, and contributing to the development of high-quality medical products. The ideal candidate will have a strong understanding of GMP, ISO 13485, and clean-room manufacturing environments.
Key Responsibilities:
- Optimize manufacturing processes for medical device production
- Develop and maintain process documentation in line with regulatory standards
- Collaborate with R&D, Quality Assurance, and Production teams
- Support validation activities (IQ, OQ, PQ) and risk assessments
- Troubleshoot production issues and implement corrective/preventive actions
- Ensure compliance with ISO 13485, FDA, and EU MDR requirements
Requirements:
- Degree in Mechanical, Biomedical, or Manufacturing Engineering
- Minimum 4 years of experience in medical device manufacturing
- Strong knowledge of GMP, ISO 13485, and regulatory compliance
- Experience with clean-room protocols and validation processes
- Proficiency in CAD and process simulation tools
- Excellent analytical and communication skills
- Fluent in English; Polish language skills are an advantage
Contract Details:
- Flexible working hours
- Competitive freelance rates
- Duration: 3-6 months with potential for extension
- Hybrid or remote work options depending on project needs
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