Manufacturing engineer

il y a 2 jours

Lyon, Auvergne-Rhône-Alpes, France EPM Scientific Temps plein

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

Location: Lyon, France

Contract Duration: 12 months

Start Date: Immediate

Engagement Type: Freelance

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 Lyon, offering the opportunity to contribute to the development and scale-up of Class II and III medical devices in a regulated, high-performance environment.

Role Overview

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.

Key Responsibilities

  • Develop, implement, and validate manufacturing processes for new and existing medical devices.
  • Lead process characterization, risk analysis (PFMEA), and control strategy development.
  • Prepare and execute IQ/OQ/PQ protocols for equipment and process validation.
  • Support design transfer activities and ensure readiness for commercial manufacturing.
  • Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
  • Ensure full documentation and traceability in accordance with ISO 13485, FDA 21 CFR Part 820, and EU MDR.
  • Collaborate with suppliers to ensure component quality and process capability.
  • Provide technical support for non-conformance investigations and CAPA implementation.

Candidate Profile

  • 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.
  • Demonstrated expertise in process validation, equipment qualification, and cleanroom operations.
  • Strong working knowledge of GMP, FDA QSR, and EU MDR requirements.
  • Proficiency in CAD software, statistical analysis tools (e.g., Minitab), and ERP/MES systems.
  • Fluent in English; proficiency in Spanish is advantageous.

Preferred Qualifications

  • Six Sigma Green or Black Belt certification.
  • Experience with Class III implantable devices or high-volume disposables.
  • Familiarity with automation, robotics, and Industry 4.0 technologies.

Offer

  • Competitive daily rate.
  • Opportunity to work on innovative, life-saving technologies.
  • Support with relocation logistics if required.
  • Collaborative and international working environment.

Desired Skills and Experience
Medical devices

Validation

Manufacturing

ISO13485

CAPA

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