Process Engineer

medtechrec; Konstanz; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading MedTech company located in Baden-Württemberg, Germany, is seeking a Process/Industrialization Engineer to oversee industrialization and process validation. Responsibilities include planning IQ/OQ/PQ, managing process capability studies, and ensuring compliance with regulatory standards. The ideal candidate will have technical qualifications in engineering, experience in regulated environments, and excellent communication skills in German and English. This role emphasizes both hands-on work and meticulous documentation.

Qualifikationen

• Several years of experience as a Process/Industrialization Engineer in a regulated environment.
• Experience with PFMEA, Control Plan, CTQ methodology.
• Strong documentation and compliance skills.

Aufgaben

• Industrialization and process validation of manufacturing processes.
• Planning and execution of IQ/OQ/PQ including validation strategy.
• Development of PFMEA and establishment of process capability studies.

Kenntnisse

Process engineering

Statistical analysis

Excellent communication skills (German & English)

Hands-on mentality

Ausbildung

Technical studies (process engineering, mechanical engineering, medical technology)

Jobbeschreibung

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)