Mechanical Engineer
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We are seeking a highly skilled and motivated Mechanical Engineer to support the development, optimization, and validation of manufacturing processes in the medical device industry. This role involves working closely with cross-functional teams to ensure efficient, high-quality, and regulatory-compliant manufacturing processes. The ideal candidate will have experience in process development, design for manufacturability, and continuous improvement methodologies.
Key Responsibilities
- Develop, optimize, and validate manufacturing processes for medical devices to ensure efficiency, cost-effectiveness, and compliance with regulatory standards (FDA, ISO 13485, etc.).
- Collaborate with R&D, Quality, and Production teams to support the transition of new products from design to full-scale manufacturing.
- Perform root cause analysis and implement corrective actions to improve production yields and product quality.
- Utilize CAD software (SolidWorks) to design and modify fixtures, tooling, and equipment.
- Conduct process capability studies, risk assessments, and validation protocols (IQ, OQ, PQ) to ensure process reliability and repeatability.
- Support automation initiatives to enhance production efficiency and reduce human error.
- Develop and maintain standard operating procedures (SOPs) and technical documentation.
- Identify and implement lean manufacturing and Six Sigma principles to drive continuous improvement.
- Ensure compliance with Good Manufacturing Practices (GMP) and other industry standards.
- Train and provide technical support to production personnel.
Qualifications
- Bachelor’s/Master's degree in Mechanical Engineering, Manufacturing Engineering, or related discipline.
- Minimum 3 years of experience.
- CAD expertise (SolidWorks) and CAD Data Management.
- Master manufacturing Data Management inside ERP systems.
- Experience with ISO 13485, FDA regulations, and Good Manufacturing Practices (GMP).
- Problem-solving oriented.
- Team spirit, communication, and project management skills.
- Fluent in French & English.
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