Manufacturing Process Senior Engineer

Manufacturing Process Senior Engineer

Novocure

Krakow, Poland

About the role:

The Manufacturing Process Senior Engineer is responsible for designing and optimizing manufacturing processes for medical devices to ensure they are reliable, cost-effective, and compliant with industry standards. This includes transforming product designs into fully documented, industrialized, and scalable production processes.

The role involves creating and maintaining key production documentation (e.g., work instructions, inspection criteria) and supporting validation activities. Frequent travel to manufacturing sites will be required during process design and validation, in coordination with other engineering teams and departments.

The engineer will also assess design changes from a manufacturing perspective and work closely with validation and sustaining engineering teams to implement these changes reliably and in compliance with regulations.

Your responsibilities:

• Design and implement manufacturing processes to ensure efficiency, reliability, and regulatory compliance in medical device production;
• Apply Lean, Six Sigma, and DFM (Design for Manufacturing) principles to improve process performance and minimize waste;
• Collaborate with validation and engineering teams to industrialize and validate processes for new and existing products;
• Analyze process data using statistical tools to drive continuous improvement and enhance manufacturing capability;
• Conduct site visits to monitor performance, resolve issues, and support implementation of corrective actions;
• Provide documentation of processes, critical parameters, control points, and inspection criteria to meet compliance and quality standards;
• Define inspection frequencies to optimize quality control while managing cost and efficiency;
• Act as a subject matter expert (SME) during audits, supplier qualification, and selection processes;
• Support supply chain and production teams with technical guidance, training, and knowledge transfer;
• Participate in OEM process design during new product introductions and modifications of existing manufacturing processes.

Your profile:

• Bachelor’s degree in industrial, manufacturing, or related engineering field;
• Proven experience in manufacturing engineering, preferably in the medical device or electronics sector;
• Strong knowledge of Lean, Six Sigma, and DFM principles; certification is a plus;
• Familiarity with PCB manufacturing and IPC standards is highly desirable;
• Working knowledge of FDA QSR (21 CFR 820), ISO 13485, and other relevant regulatory standards would be a great advantage;
• Proficient in statistical analysis and process improvement tools;
• Strong communication and collaboration skills for cross-functional teamwork;
• Proficient in English language both spoken and written (C1);
• Willingness and ability to travel frequently (20%) to domestic and international manufacturing sites.

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