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