Project Engineer - Equipment & Industrialization

* 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.

Quote job ref

JN-082026-7086989

Job Function

Engineering & Manufacturing

Specialisation

Process Engineering

Industry

Healthcare / Pharmaceutical

Where

Lausanne Region

Contract Type

Permanent

Job Reference

JN-082026-7086989

Job Nature

Home Office