Mechanical Engineer

Physiol; Luik; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

Physiol is seeking a highly skilled Mechanical Engineer in Luik, Belgium, to support the development and validation of manufacturing processes in the medical device industry. The ideal candidate will have a strong background in process development and design for manufacturability.

This role involves cross-functional collaboration to ensure regulatory compliance and efficient production. Candidates should have a Bachelor’s/Master's degree, CAD expertise, and a minimum of 3 years of relevant experience.

Qualifications

• Minimum 3 years of experience in manufacturing processes.
• Experience with ISO 13485 regulations and GMP compliance.
• Fluent in French and English.

Responsabilités

• Develop, optimize, and validate manufacturing processes for medical devices.
• Collaborate with R&D, Quality, and Production teams.
• Implement corrective actions to improve production yields.

Connaissances

Process Development

Design for Manufacturability

Continuous Improvement Methodologies

CAD (SolidWorks)

Team Spirit

Formation

Bachelor’s/Master's degree in Mechanical Engineering

Outils

SolidWorks

ERP Systems

Description du poste

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.