Senior Manufacturing Engineer

The Senior Process Engineer is responsible for process validation, manufacturing support, and process optimization within a regulated medical device manufacturing environment. The role focuses on improving operational efficiency, reducing scrap, and ensuring product quality through data analysis, Lean Manufacturing, Six Sigma methodologies, and statistical tools. This position acts as a Subject Matter Expert (SME) for manufacturing processes, providing technical support to production and cross-functional teams while supporting process validation, equipment qualification, troubleshooting, new product introductions, and regulatory compliance in accordance with GMP, GDP, and ISO 13485 requirements.

YOUR RESPONSIBILITIES

• Lead continuous improvement initiatives focused on productivity, quality, cost reduction, and operational efficiency within a medical device manufacturing environment.
• Analyze manufacturing data to identify trends and root causes, and perform process optimization for scrap reduction and efficiency improvement using Lean Manufacturing, Six Sigma methodologies, statistical analysis, and process capability studies.
• Act as Subject Matter Expert (SME) for assigned manufacturing processes, optimizing manufacturing operations to ensure product quality, process consistency, and operational efficiency.
• Develop and execute process validation activities including IQ/OQ/PQ protocols and validation documentation.
• Provide day-to-day manufacturing and business support to production operations and cross-functional teams, including troubleshooting and implementation of corrective actions for manufacturing and process-related issues.
• Collaborate with production, quality, maintenance, and engineering teams to improve manufacturing performance and process reliability.
• Support new product introductions, process transfers, equipment qualifications, risk assessments, and FMEA activities, while also supporting internal and external audits and ensuring compliance with regulatory and quality standards.
• Ensure manufacturing processes comply with GMP (Good Manufacturing Practice) and GDP (Good Documentation Practice) requirements.

• Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical field.
• Minimum 5+ years of experience in medical device manufacturing or other highly regulated industries.
• Lean Six Sigma Green Belt certification desired.
• Strong experience in manufacturing engineering, process optimization, and validation methodologies.
• Hands‑on experience with process validation, equipment qualification, and manufacturing process controls.
• Strong understanding of GMP, GDP, ISO 13485, and regulated manufacturing environments.
• Knowledge of statistical analysis tools and structured problem‑solving methodologies.
• Excellent analytical, communication, and project management skills.
• Experience with ERP/MES systems and manufacturing data reporting tools is an advantage.
• Power BI skills and experience with data visualization/reporting tools are a plus.

Process Engineering Supervisor II

• A responsible and varied job in a global company with a strong local presence.
• Progressive employment conditions with long‑term perspective.
• A high level of personal responsibility and independent work.
• A safe space for creative thinking and learning at the workplace.
• Bonus system, extra vacation days and many other benefits.