Technical Project Lead & Process Design

ITech Consult AG

Risch-Rotkreuz

Presencial

CHF 18.000 - 32.000

Tempo parcial

Há 2 dias
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Resumo da vaga

ITech Consult AG is seeking an experienced Technical Project Lead & Process Design for its client in Rotkreuz, Switzerland. The role focuses on designing and industrializing robust production processes for instrument components and managing external supplier transfers.

A strong SPC/CPk/DSx background and leadership in technology transfers are essential. Responsibilities include defining validation strategies, establishing process capability baselines, and coordinating cross-functional teams

Qualificações

  • Bachelor’s or higher technical degree in a related field.
  • 5–6+ years in manufacturing process design or supplier management.
  • Strong SPC, Cpk, MSA, and pFMEA knowledge.

Responsabilidades

  • Design, optimize, and industrialize manufacturing/testing processes for instrument components.
  • Define validation strategies (IQ/OQ/PQ) and establish Cp/Cpk baselines.
  • Embed DfX with R&D to prevent bottlenecks and drive yields.
  • Lead end-to-end technology transfers between external contract manufacturers.
  • Establish QMPs, schedules, milestones; report progress to MSAT/GIN.
  • Monitor supplier KPIs and manage deviations and SCARs.
  • Conduct supplier qualifications and drive line ramp-ups and capacity expansions.

Conhecimentos

SPC
Cpk analysis
MSA
pFMEA
External transfers
Project leadership
ISO 13485
GMP/FDA
English fluency
Travel readiness

Formação

University degree in Mechanical/Electrical/Mechatronics/Process/Industrial Engineering

Ferramentas

PM certifications (PMP/IPMA/Agile)

Descrição da vaga

This job posting was published here directly by one of our clients. The State Secretariat for Economic Affairs has no control over its content or quality.

Technical Project Lead & Process Design

ITech Consult AG Vacant since : 03.11.2026 6343 Risch (ZG) 10% By agreement Temporary

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 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

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 (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, 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
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 (written and spoken). Willingness to travel globally (approx. 20-30%) for supplier on‑site process reviews, audits, and transfer milestones
Job Reference

Reference Nr.: 925374
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

About us

ITech Consult is an ISO 9001:2015‑certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.

  • ITech Consult AG
  • Work location 6343 Risch (ZG)
  • Workload 10%
  • Employment start By agreement
  • Employment duration Temporary
  • By online Online form
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