Senior Process Engineer – MedTech Industrialization

PlusOne; Luik; On-site; EUR 70,000 - 100,000; Full time

Job summary

Man & Science, Liège, Belgium, seeks a Senior Process Engineer to own the industrialization of our implantable neuromodulation device and its external components. You will build manufacturing processes, select manufacturing partners and ensure the product can be produced reliably, reproducibly and at the right cost.

The role involves close collaboration with R&D for DFM input, interaction with contract manufacturers, and managing process validation, IQ/OQ/PQ, and cost optimization.

Qualifications

• Engineering degree in electromechanical, mechanical, or electrical discipline.
• 5+ years of experience in industrialization, NPI, process or manufacturing engineering.
• Experience in regulated environments; Medical Devices ISO 13485 / MDR preferred.
• Hands-on experience with process validation and at least one manufacturing transfer to an external contract manufacturer.
• Experience with electronics, PCBA or EMS manufacturing is a strong advantage.
• Fluent in English; French and/or Dutch are an asset.

Responsibilities

• Lead industrialization projects for PCBAs, mechanical components and implant-related parts, from design transfer through manufacturing readiness.
• Provide Design for Manufacturing (DFM) input and define robust manufacturing processes.
• Act as the main technical interface with contract manufacturers on process, quality, changes and manufacturing issues.
• Define the manufacturing strategy, including supplier selection, second-source strategies and assessment of new technical partners.
• Plan and follow process validation and qualification, including IQ/OQ/PQ, pfMEA and control plans.
• Drive manufacturing cost optimization through DFM, process improvements and alternative technical solutions.
• Provide technical input for supplier qualification, audits and quality agreements.
• Prepare technical documentation including specifications, validation protocols and reports, and design-transfer documentation.
• Support manufacturing planning and coordinate technical requirements with supply-chain and inventory needs.

Skills

Industrialization

Process engineering

Supplier management

DFM

Regulated environment

Medical devices / ISO 13485

Project ownership

Cost optimization

Electronics PCBA

Education

Engineering degree (electromechanical / mechanical / electrical)

Tools

Validation protocols

Manufacturing transfer

Job description

Man & Science, Liège, Belgium, seeks a Senior Process Engineer to own the industrialization of our implantable neuromodulation device and its external components. You will build manufacturing processes, select manufacturing partners and ensure the product can be produced reliably, reproducibly and at the right cost.

The role involves close collaboration with R&D for DFM input, interaction with contract manufacturers, and managing process validation, IQ/OQ/PQ, and cost optimization.