Process Engineer

Responsibilities:

• Responsibility for industrialization and process validation of manufacturing and special processes (end-to-end)
• Planning and execution of IQ/OQ/PQ including validation strategy, protocols, evaluation and final reports
• Development and moderation of PFMEA including action planning, proof of effectiveness and ongoing maintenance
• Establishment of process capability studies (Cp/Cpk), SPC approaches and process windows for critical characteristics (CTQs)
• Definition and implementation of control plans, test plans, in-process controls and release criteria
• Management of ramp-up activities: line/plant capability, throughput, yield/FPY, bottleneck analysis, stabilization
• Interface management with production, quality, R&D, supply chain and external partners (CMOs/suppliers)
• Responsibility for process documentation: SOPs, work instructions, parameter lists, traceability, change documentation
• Support/leadership of root cause analyses and implementation of corrective/preventive actions (CAPA)
• Qualification of equipment and supplier processes (FAT/SAT, acceptance testing, process approvals, outsourcing management)
• Ensuring compliance with regulatory requirements (MDR/ISO 13485) during the production transfer, including the design transfer interface.
• Experience in dental/implant manufacturing or high-precision manufacturing (e.g., CIM/CNC/grinding/polishing)

Profile Requirements:

• Completed technical studies (e.g. process engineering, mechanical engineering, medical technology, production engineering) or equivalent experience
• Several years of experience as a Process/Industrialization Engineer in a regulated environment (ideally MedTech)
• Demonstrable practice in IQ/OQ/PQ, statistical analysis and auditable documentation
• Experience with PFMEA, Control Plan, CTQ methodology and process capability analyses (Cp/Cpk, SPC)
• Hands-on mentality on the shop floor, but at the same time strong in documentation and compliance
• Structured, independent and goal-oriented work style
• Reliability, accuracy and a strong commitment to quality
• Excellent communication skills (German & English)