Technical Project Lead & Process Design

Flexsis AG, Filiale Basel LS; Rotkreuz; On-site; CHF 120,000 - 180,000; Full time

Job summary

Flexsis AG is seeking a reliable Technical Supplier Manager for Roche Diagnostics in Rotkreuz. The role focuses on designing, validating, and optimizing manufacturing and testing processes for instrument components across the supplier base, with emphasis on DfX and process capability.

Responsibilities include leading PFMEA, quality controls, and root-cause investigations, while collaborating with R&D to prevent bottlenecks and drive yield improvements. Travel globally approx. 20–30% is required.

Qualifications

• University degree in a technical field (Mechanical, Electrical, Mechatronics, Process/Industrial Engineering).
• 5-6+ years in manufacturing process design, supplier management, industrialization, or manufacturing engineering; medical devices/IVD/pharma/precision high-tech preferred.
• Proven hands-on experience in designing, qualifying, and optimizing manufacturing and test processes with SPC, Cpk, MSA, and pFMEA.
• Knowledge of ISO 13485, GMP/FDA, IQ/OQ/PQ, and change control procedures.
• Pragmatic problem solver with strong intercultural communication and stakeholder management.
• English and German proficiency; willingness to travel globally (20–30%).

Responsibilities

• Design, optimize, and industrialize manufacturing and testing processes for instrument components and assemblies across the external supply base.
• Define process validation strategies (IQ/OQ/PQ), verification protocols, and process capability baselines (Cp/Cpk, tolerance studies, Gage R&R).
• Partner with R&D to embed DfX principles early in development to prevent bottlenecks and improve yield.
• Lead PFMEA, establish poka-yoke controls, and drive root-cause investigations to mitigate process vulnerabilities.
• Monitor supplier process stability, KPIs, and component quality trends throughout the lifecycle.

Skills

Process design

SPC

Cpk

MSA

pFMEA

Design for Manufacturing (DfX)

Change management

Stakeholder management

Quality standards awareness

Education

Bachelor's, Master's or Higher Technical Diploma in Mechanical/Electrical/Mechatronics/Process/Industrial Engineering

Job description

Description of the company

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%

Role & 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


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

Candidate Profile

• 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