925374 -manufacturing Transfer Engineer in Zug

Technical Supplier Manager: Manufacturing Transfer Engineer/Process Design / Industrialization / DFX / Process Design/ Stewardship / Project Governance Operations Support / statistical process control (SPC)/ capability studies (Cpk) / measurement systems analysis / English / Deutsch Background: The Perfect Candidate possesses a relevant technical degree and demonstrated expertise in statistical process control and project leadership, specifically in external technology transfers and line ramp-ups. Additionally, strong knowledge of precision manufacturing technologies and production cost optimization is required. Tasks & Responsibilities: Manufacturing Process Design & Industrialization (Core Activity) Process Architecture & Development: Actively design, optimize, and industrialize robust manufacturing and testing processes for instrument components, electronics, and precision assemblies across the external supply base Process Capability & Validation: Define process validation strategies (IQ/OQ/PQ), design verification protocols, and establish process capability baselines (Cp/Cpk analysis, tolerance studies, and Gage R&R) Design for Excellence (Df X): Partner closely with R&D during early product development to embed Design for Manufacturing, Assembly, and Testability principles into component designs, preventing manufacturing bottlenecks and driving yield optimization Process Risk & Mitigation: Lead process failure mode and effects analysis (p FMEA), establish poka-yoke (error-proofing) controls, and drive root-cause investigations to engineer out process vulnerabilities Technical Project Leadership & External-to-External (E2 E) Transfers Lead Technology Transfers: Steer end-to-end technical transfers between external contract manufacturers and suppliers (External-to-External), including production line relocations, tool duplications, and second-source qualifications Project Governance & Milestones: Establish qualification master plans (QMPs), define project schedules, align critical milestones, and report progress transparently to cross-functional leadership within MSAT and GIN Cross-Partner Synchronization: Lead technical alignment and change control across originating sites, receiving supplier facilities, Global Sourcing, Quality Assurance, and Regulatory Affairs Technical Supplier Stewardship & Operations Support Supplier Performance & Monitoring: Monitor supplier process stability, technical KPIs, and component quality trends across the complete instrument lifecycle Deviation Handling & SCARs: Lead technical problem-solving teams (8 D, Ishikawa, 5-Why) for component deviations; resolve Supplier Corrective Action Requests sustainably Supplier Technical Assessments: Conduct technical evaluations and audits of potential and existing suppliers as part of the formal supplier qualification process Operations Projects: Steer supplier-side engineering changes (without spec change), capacity expansions, and continuous line stabilization initiatives Must Haves: A University degree (Bachelor's, Master's, or Higher Technical Diploma) in Mechanical Engineering, Electrical Engineering, Mechatronics, Process Engineering, Industrial Engineering, or a related technical field At least 5–6+ years of relevant industry experience in manufacturing process design, technical supplier management, industrialization, or manufacturing engineering, ideally within medical devices, in-vitro diagnostics (IVD), pharmaceuticals, or precision high-tech equipment Process Design Expertise: Proven hands‑on track record in designing, qualifying, and optimizing manufacturing and test processes. Strong command of statistical process control (SPC), capability studies (Cpk), measurement systems analysis (MSA), and p FMEA Technical Project Leadership: Demonstrated leadership in complex technical projects, specifically external-to-external technology transfers, second-sourcing initiatives, or major line ramp-ups. Formal PM certification (PMP, IPMA, Agile) is an asset Manufacturing Technologies: Deep technical understanding of precision manufacturing technologies (e.g., injection molding, precision mechanics/machining, electronics assembly, automated testing) along with an understanding of production cost drivers and cycle time optimization Regulatory & Quality Standards: Practical knowledge of ISO 13485, GMP/FDA regulations, process validation frameworks (IQ/OQ/PQ), and formal change management procedures Mindset & Communication: Pragmatic, innovative problem solver with a "think-out-of-the-box" attitude and strong intercultural stakeholder management and communication skills Languages & Mobility: Professional fluency in English and German (written and spoken). Willingness to travel globally (approx. 20–30%) for supplier on-site process reviews, audits, and transfer milestones