Senior Molding Engineer

About the role

Biomerics is seeking a Senior Molding Engineer with extensive experience in injection molding process development and validation for medical devices. The role focuses on planning, executing, and documenting validation protocols to ensure regulatory compliance and optimal performance.

Key responsibilities

• Lead the planning and execution of validation protocols (IQ, OQ, PQ) for molding processes.
• Define critical molding parameters and maintain traceability throughout validation activities.
• Coordinate with Engineering, Quality, and Production to integrate validated processes.
• Supervise validation testing of molds and molding equipment.
• Implement process improvements to optimize performance and ensure compliance with medical device regulations.
• Participate in innovation and continuous‑improvement projects related to molding and validation.
• Train technical personnel on validated molding parameters and procedures.

Required profile

• Academic background in Mechanical, Electromechanical, Industrial Engineering or related field.
• Minimum 3 years of experience in injection molding processes within the medical device or regulated industry.
• Advanced English proficiency.

Required skills

• Injection molding process development and validation.
• Scientific Molding and/or Universal Molding knowledge.
• Process validation principles (IQ, OQ, PQ).
• Medical device regulations and standards (ISO 13485, FDA, GMP).