Mechanical Engineer

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

Purpose

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.

Qualification

• 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.

Company

BVI® is refocusing the future of vision.

As one of the fastest‑growing, diversified surgical ophthalmic businesses in the world, our purpose‑built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single‑Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com