Medical Device Validation Engineer - ISO 13485 & CFR

Physiol; Luik; Hybrid; EUR 55,000 - 70,000; Full time

Job summary

PhysIOL is seeking a highly skilled Validation Engineer to support the development, optimization, and validation of manufacturing processes in the medical device industry. The role involves working with cross-functional teams to ensure regulatory-compliant manufacturing with high quality and efficiency.

The ideal candidate will handle ISO 13485 validation, FDA regulations, and GMP, with expertise in CAD (SolidWorks) and ERP data management, delivering robust documentation and process

Qualifications

• Bachelor’s or Master’s degree in Mechanical or 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 GMP.

Responsibilities

• Drive validation of new production equipment, processes, and CSV of computerized systems linked to production and quality control processes.
• Ensure TMV validation and that methods meet quality requirements with reproducible results.
• Prepare related documentation and ensure its implementation within Quality Control and Production departments.

Skills

Problem-solving

Team spirit

Communication

Project management

Fluent in French

Fluent in English

Education

Bachelor’s in Mechanical Engineering

Master’s in Manufacturing Engineering

Tools

SolidWorks

CAD Data Management

ERP Data Management

Job description

PhysIOL is seeking a highly skilled Validation Engineer to support the development, optimization, and validation of manufacturing processes in the medical device industry. The role involves working with cross-functional teams to ensure regulatory-compliant manufacturing with high quality and efficiency.

The ideal candidate will handle ISO 13485 validation, FDA regulations, and GMP, with expertise in CAD (SolidWorks) and ERP data management, delivering robust documentation and process