Virtual Manufacturing Engineer

Contract Opportunity : Manufacturing Engineer - Medical Devices (ISO 13485)

Contract Duration : 12 months

Start Date : Immediate

Engagement Type : Freelance / B2B / Temporary Employment

A leading medical device manufacturer is seeking an experienced Manufacturing Engineer to support advanced production operations in compliance with ISO 13485 and EU MDR standards. This is a 12-month contract role based in Barcelona, offering the opportunity to contribute to the development and scale-up of Class II and III medical devices in a regulated, high-performance environment.

The successful candidate will be responsible for the design, validation, and optimization of manufacturing processes, ensuring full compliance with applicable regulatory frameworks. The role requires close collaboration with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Supply Chain.

Develop, implement, and validate manufacturing processes for new and existing medical devices.

Lead process characterization, risk analysis (PFMEA), and control strategy development.

Support design transfer activities and ensure readiness for commercial manufacturing.

Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.

Collaborate with suppliers to ensure component quality and process capability.

Degree-qualified in Mechanical, Biomedical, or Manufacturing Engineering (BSc / MSc).

Minimum 5 years of experience in medical device manufacturing within an ISO 13485-compliant environment.

Proficiency in CAD software, statistical analysis tools (e.g., Minitab), and ERP / MES systems.

Fluent in English; proficiency in Spanish is advantageous.

Competitive daily rate.

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