Technical Project Lead & Process Design

Flexsis; Risch-Rotkreuz; On-site; CHF 120,000 - 150,000; Full time

Job summary

Flexsis, a member of the Interiman Group, is seeking a Technical Supplier Manager – Technical Project Lead & Process Design for Roche Diagnostics in Rotkreuz. Start 01.12.2026; contract extension likely; workplace Rotkreuz; workload 100%.

You will design and optimize manufacturing/test processes, validate them (IQ/OQ/PQ), and drive DfX with R&D to improve yields. The role requires 5–6+ years in process design or supplier management in medical devices or high-tech equipment, plus expertise in

Qualifications

• Bachelor's or higher in a technical engineering discipline.
• 5–6+ years in manufacturing process design or supplier management.
• Knowledge of ISO 13485 and GMP/FDA environments.
• Experience with process validation and reliability testing.
• Willingness to travel globally (20–30%).

Responsibilities

• Design, optimize, and industrialize manufacturing and testing processes.
• Define validation strategies (IQ/OQ/PQ) and capability baselines.
• Collaborate with R&D to embed DfX in component designs.
• Lead pFMEA, implement poka-yoke controls, and root-cause analysis.
• Monitor supplier process performance and quality trends.

Skills

Process design

Statistical methods (SPC, Cp/Cpk)

Root-cause analysis

Intercultural communication

English & German proficient

Education

Bachelor's/Master's in Mechanical/Electrical/Mechatronics/Industrial Engineering

Experience in medical devices/IVD/pharma

Tools

IQ/OQ/PQ

MSA

pFMEA

Gage R&R

Cp/Cpk analysis

Job description

Flexsis is a company of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise as well as the competencies within the Interiman Group, we offer tailored solutions in personnel consulting.

For our client Roche Diagnostics in Rotkreuz, we are looking for a reliable and motivated (m/f/d)

Technical Supplier Manager – Technical Project Lead & Process Design

Start Date: 01.12.2026

Latest Possible Start Date: 01.01.2027

Planned Duration of Employment: 18 Monate

Extension: very likely (with approved budget, project extension,...)

Workplace: Rotkreuz

Workload: 100%

• 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
• Supplier Performance & Monitoring: Monitor supplier process stability, technical KPIs, and component quality trends across the complete instrument lifecycle

• 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
• 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