Technical Project Lead & Process Design

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 (DfX): 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 (pFMEA), establish poka-yoke (error-proofing) controls, and drive root-cause investigations to engineer out process vulnerabilities

Technical Project Leadership & External-to-External (E2E) 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, Roche 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 (8D, 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

Your background:

• A University degree in Mechanical Engineering, Electrical Engineering, Process Engineering or a related technical field
• At least 5–6+ years of relevant industry experience in manufacturing process design, technical supplier management, or manufacturing engineering, ideally within medical devices, in-vitro diagnostics (IVD)
• 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 pFMEA
• 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
• 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.