Job Description

Purpose of the positionAn international company in the medical sector is looking for a Manufacturing Engineer with proven experience in precision mechanical assemblies, 3D printing, and participation in production line transfers.This role is key in the implementation and validation of new processes, ensuring efficiency, regulatory compliance, and world-class quality.Main Responsibilities:Execute manufacturing process transfer and validation activities, ensuring compliance with quality standards and regulatory requirements.Develop and optimize precision mechanical assembly and 3D printing processes, ensuring dimensional accuracy and functional performance.Prepare and maintain BOMs, process routes, work instructions, and technical documentation according to GMP guidelines.Implement continuous improvement tools (Lean, Six Sigma) to increase productivity and reduce waste.Support the design and validation of tooling, fixtures, and production layouts.Conduct IQ/OQ/PQ validations, capability studies (Cp, Cpk), and root cause analysis.Train operational staff in new processes and safe manufacturing practices.Ensure compliance with safety, quality, and environmental standards in operations.Coordinate with local and international multidisciplinary teams to ensure successful transition of transferred processes.Requirements:Bachelor’s degree in Industrial, Mechanical, Biomedical, or Materials Engineering (required).Minimum 3 years of experience in manufacturing within regulated industries (preferably medical devices).Proven experience in precision mechanical assemblies and 3D printing processes.Knowledge of process validations (IQ/OQ/PQ) and continuous improvement methodologies.Proficiency in statistical tools (SPC, Minitab, GR&R).Intermediate to advanced English; able to interact with global teams.Valid visa and passport.Preferred Qualifications:Experience with international process transfers.Green Belt certification or Lean Six Sigma training.Knowledge of ISO 13485 and FDA regulations.Experience using SolidWorks design software.Key Competencies:Analytical thinking & problem-solvingPlanning and organizationResults orientationEffective communicationCollaborative and intercultural teamworkFocus on quality and continuous improvementWhat’s Offered:Participation in an international technology transfer project.Professional growth in a global, innovation-driven company.Benefits above regular requirements.

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