Technical Project Lead & Process Design

ITech Consult AG; Zug; Presencial; CHF 120.000 - 170.000; Tempo integral

Resumo da vaga

Roche Diagnostics in Rotkreuz, Switzerland, seeks an experienced Technical Supplier Manager to bridge internal engineering and external supplier networks. You will own instrument component design, process validation, and industrialization across supplier sites, ensuring robust production and high-quality output.

Ideal candidates bring a university technical degree and 5–6+ years in manufacturing process design, supplier management, and international tech transfers.

Qualificações

• Relevant university degree in a technical field.
• Hands-on SPC, Cpk, MSA, and pFMEA experience.
• Leadership in external technology transfers and line ramp-ups.
• Knowledge of ISO 13485 and GMP/FDA is beneficial.

Responsabilidades

• Design, optimize, and industrialize robust manufacturing and testing processes for instrument components across external suppliers.
• Define validation strategies (IQ/OQ/PQ) and establish Cp/Cpk baselines and Gage R&R.
• Embed DfX principles with R&D to prevent bottlenecks and drive yield optimization.
• Lead PFMEA, poka-yoke controls, and root-cause investigations.
• Steer end-to-end technical transfers between external contract manufacturers.
• Establish qualification master plans, schedules, milestones, and progress reporting.
• Align across originating/receiving sites, Roche Global Sourcing, QA, and Regulatory Affairs.
• Monitor supplier performance and component quality trends throughout the lifecycle.
• Lead 8D, Ishikawa, 5-Why problem solving for deviations.
• Conduct supplier technical assessments and audits as part of qualification.
• Drive supplier-side engineering changes, capacity expansions, and continuous line stabilization.

Conhecimentos

Process design

Technical project leadership

SPC

Cpk analysis

MSA

pFMEA

English

German

Travel readiness

Formação

Engineering degree (Mechanical / Electrical / Mechatronics / Process / Industrial)

Descrição da vaga

Technical Supplier Manager: Process Design / Industrialization / DFX / Process Design/ Stewardship / Project Governance Operations Support / statistical process control (SPC)/ capability studies (Cpk) / measurement systems analysis / English / Deutsch

Background: At Roche Diagnostics, we develop and deliver life‑critical diagnostic solutions that empower healthcare professionals and patients around the globe. Within the Manufacturing Science and Technology (MSAT) organization, an essential pillar of our Global Instrument Network (GIN), we are seeking an experienced, driven Technical Supplier Manager (m/f/d). In this role, you will be the vital technical bridge connecting our internal engineering and operations teams with our global network of contract manufacturing partners. You will take technical ownership of instrument components, subassemblies, and production lines. A primary pillar of your daily work is robust manufacturing process design, architecting, validating, and industrializing stable production processes both internally and across supplier sites. Alongside this focus, you will serve as the Technical Project Lead for Technical Transfers (External to External), leading international technology migrations, second‑sourcing ramp‑ups, and capacity expansions to ensure long‑term supply security and premium product quality.

The Perfect Candidate

posesses 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

• 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
• 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
• 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

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 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
• 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

Reference Nr.: 925374

Rolle: Technical Project Lead & Process Design

Industrie: Pharma

Location: Rotkreuz

Pensum: 100%

Start: 01.12.2026 (01.01.2027)

Duration: 18++ Months

Deadline: 09/10/2026