Manufacturing Process Engineer

We are looking for a Manufacturing Process Engineer to join our team and play a key role in optimizing manufacturing processes. In this role, you will identify and resolve technical and process-related issues, drive continuous improvement initiatives, and ensure manufacturing processes remain efficient, reliable, and compliant with quality and regulatory requirements.

This position is ideal for an engineer with 3+ years of experience in process, manufacturing, or production engineering who enjoys solving complex technical challenges.

Key Responsibilities

• Process Optimization: Monitor and optimize machine parameters (temperature, pressure, speed) for chemical mixing, liquid/powder filling lines and injection molding process
• Troubleshooting, non-conformance and CAPA resolution: Investigate and analyze the root causes of technical non-conformances (NC) on the production floor, create and implement corrective and preventive actions (CAPA)
• Process Risk Assessment (FMEA): Lead and update Process FMEA (pFMEA) studies to identify, evaluate and mitigate manufacturing risks, ensuring process controls are robust enough to protect product quality
• Standardization: Write and update Standard Operating Procedures (SOPs), technical work instructions for operators and setup parameters for production machinery
• Technology/Design Transfer: Support the transfer of manufacturing processes and technical "know-how" to contract manufacturing partners
• Supplier Process Oversight: Oversee and approve validation phases (IQ/OQ/PQ) conducted at supplier sites to ensure external production readiness
• Documentation & Change Control: Review, interpret and update technical drawings and specifications for medical components. Participate in the engineering change control process to maintain accurate technical documentation
• Technical Audits and Support: Conduct technical process audits at external facilities and lead root-cause analysis for any manufacturing issues occurring at the supplier’s end
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Requirements:

• Education: Bachelor’s degree in mechanical engineering, Chemical/Process engineering, Industrial engineering, Mechatronics, or a related field.
• Experience in Medical Devices (ISO 13485, ISO 14971) and Pharmaceuticals is highly preferred
• Technical Skills: Strong ability to read and interpret technical drawings. Proficiency in using CAD software is highly preferred. Good understanding of automation and mechanical systems
• Experience: Minimum 3 years of experience as a Process, Manufacturing, or Production Engineer in a structured industrial environment
• Languages: Fluency in English (written and spoken) is required for communication within the international group and external partners

What We Offer:

• Structured onboarding and continuous learning
• Opportunity to professional growth and career development
• Stable position in a specialized healthcare sector
• Supportive and professional working environment
• Opportunity to travel internationally and contribute to global projects

Please submit your CV in English.