Medical Device Process Engineer — GMP & Lean

BVI Medical; Luik; Sur place; EUR 50 000 - 68 000; Plein temps

Résumé du poste

BVI Medical in Liège, Belgium seeks a Mechanical Engineer to develop, optimize, and validate manufacturing processes for medical devices. You will collaborate with R&D, Quality, and Production teams to transition products from design to full-scale manufacturing.

Responsibilities include root-cause analysis, implementing improvements, and creating SOPs while ensuring GMP, ISO 13485, and FDA compliance. Fluent in French and English is required.

Qualifications

• Bachelor’s or Master’s degree in Mechanical/Manufacturing Engineering.
• Minimum 3 years of experience in manufacturing/process development for medical devices.
• Proficiency with SolidWorks and ERP data management.
• Knowledge of ISO 13485, FDA regulations, and GMP.

Responsabilités

• Develop, optimize, and validate manufacturing processes for medical devices.
• Collaborate with R&D, Quality, and Production teams to transition products to manufacturing.
• Perform root cause analysis and implement corrective actions to improve yields and quality.
• Utilize CAD software (SolidWorks) to design fixtures, tooling, and equipment.
• Conduct process capability studies, risk assessments, and validation protocols (IQ, OQ, PQ).
• Support automation initiatives to improve efficiency and reduce errors.
• Develop and maintain SOPs and technical documentation.
• Identify and implement lean manufacturing and Six Sigma principles.
• Ensure GMP and regulatory compliance; train production personnel.

Connaissances

French (Fluent)

English (Fluent)

Problem-solving

Teamwork

Project management

Regulatory compliance

Formation

Bachelor’s or Master’s degree in Mechanical/Manufacturing Engineering

Outils

SolidWorks

ERP data management

ISO 13485 & GMP knowledge

Description du poste

BVI Medical in Liège, Belgium seeks a Mechanical Engineer to develop, optimize, and validate manufacturing processes for medical devices. You will collaborate with R&D, Quality, and Production teams to transition products from design to full-scale manufacturing.

Responsibilities include root-cause analysis, implementing improvements, and creating SOPs while ensuring GMP, ISO 13485, and FDA compliance. Fluent in French and English is required.