Project Engineer - Equipment & Industrialization

Michael Page; Lausanne; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Home office one day per week

Flexible working hours

Zusammenfassung

Michael Page is seeking an experienced engineer in the Lausanne area to lead industrialization projects in the Medical Devices sector. You will drive manufacturing process development, transfer to production and equipment design from concept to implementation.

The role requires a Master’s degree in engineering, 5+ years in process development and proven GMP/ISO 13485 experience. You will work cross-functionally with R&D, Manufacturing, Quality and external suppliers, including occasional

Qualifikationen

• Master's degree or equivalent in Mechanical/Industrial Engineering.
• 5+ years in process development, industrialization, equipment engineering or technology transfer.
• Experience in GMP and ISO 13485 regulated environments.
• Strong project engineering experience delivering within cost, quality and timeline.
• Solid mechanical design skills and 3D CAD experience (SolidWorks/CATIA/Inventor).

Aufgaben

• Lead industrialization projects from development through production transfer.
• Act as Work Package Leader, managing planning, timelines and costs.
• Design, develop and commission manufacturing equipment and tooling.
• Develop 3D CAD models, drawings, tolerance analyses and documentation.
• Define workflows and ensure manufacturability of designs.
• Collaborate with R&D, Manufacturing, Quality and Maintenance.
• Support validation activities (EQ/OQ/PQ) and generate SOPs and batch records.
• Ensure robust Design Transfer to Manufacturing and support production.
• Participate in technology transfer and regulatory-compliant projects.
• Perform risk assessments (eFMEA/pFMEA) and drive mitigation actions.

Kenntnisse

Project engineering

Mechanical design

Problem solving

Cross-functional communication

Ausbildung

Master's degree in Mechanical Engineering

Engineering-related master’s degree

Tools

SolidWorks

CATIA

Inventor

Jobbeschreibung

• Development, industrialization and transfer of manufacturing processes.

• Medical Devices sector
• Development, industrialization and transfer of manufacturing processes.

About Our Client

Our client is an established company operating in the Medical Devices sector, based in the Lausanne area.

Job Description

• Lead industrialization projects from manufacturing process development through to production transfer, ensuring quality, cost and timeline objectives are met.
• Act as Work Package Leader within larger projects, managing planning, timelines, costs and deliverables.
• Design, develop and commission manufacturing equipment, tooling, fixtures, test benches and automated systems, from mechanical concept through to implementation.
• Develop 3D CAD models, technical drawings, tolerance analyses and technical documentation.
• Define and industrialize complete manufacturing workflows, including raw material preparation, cleaning systems, equipment and material flows.
• Collaborate closely with R&D, Product Development, Manufacturing, Quality and Maintenance to ensure product designs are compatible with manufacturing processes.
• Define User Requirements Specifications (URS) and contribute to equipment and process specifications.
• Support the validation of manufacturing processes and equipment, including EQ, OQ and PQ activities.
• Prepare and review technical documentation, including SOPs, batch records, risk assessments, study protocols and technical reports.
• Ensure a robust and compliant Design Transfer to Manufacturing, including production documentation, training and support during the first production batches.
• Participate in technology transfer and industrialization projects towards global manufacturing sites, ensuring scalability, reproducibility and regulatory compliance.
• Participate in equipment and process risk assessments (eFMEA / pFMEA) and define appropriate mitigation actions.
• Identify and implement continuous improvement opportunities across manufacturing processes, equipment and automation.Act as a Subject Matter Expert for equipment design, process industrialization and technology transfer, providing technical support and mentoring to other engineers.

The Successful Applicant

• Master's degree or equivalent in Mechanical Engineering, Industrial Engineering or a related engineering discipline.
• 5+ years of relevant experience in process development, industrialization, equipment engineering, scale-up, validation or technology transfer, ideally within Medical Devices or Pharmaceutical environments.
• Proven experience working in a GMP and/or ISO 13485 regulated environment.
• Strong project engineering experience, with the ability to manage technical work packages and deliver projects within cost, quality and timeline constraints.
• Strong mechanical design skills and hands-on experience with 3D CAD software such as SolidWorks, CATIA or Inventor.
• Experience with automation, robotics, industrial vision or automated manufacturing systems is a strong advantage.
• Good understanding of manufacturing process development, equipment qualification and process validation.
• Structured, hands‑on and results‑oriented approach, with strong problem‑solving and communication skills.
• Comfortable working cross‑functionally with R&D, Manufacturing, Quality and external suppliers.
• Fluent in French and English, both written and spoken.

What's On Offer

• The opportunity to join an innovative Medical Devices environment and contribute directly to the industrialization of new products and manufacturing technologies.
• A highly technical and cross‑functional role combining project engineering, mechanical design, industrialization and process development.
• The opportunity to work on projects with a direct impact on manufacturing performance and production capabilities.
• A dynamic environment offering exposure to new technologies, automation and advanced manufacturing solutions.
• 1 day of home-office per week.
• Flexible working hours.

Contact

Quote job ref: JN-082026-7086989