As our Product Engineer, you will drive the development of new products under design control and you will initiate modification sheets to handle change control projects. You will play a primary role in coordinating actions with various departments (business unit, production, regulatory affairs, process validation, quality, ...) and document everything properly. In consultation with those departments, you will introduce and support the implementation of new products, process adjustments or product improvements, in line with internal and external standards. As Product Engineer you are responsible for respecting the timelines, the budget, as well as the safety and quality regulations.
For new products, you will take ownership of the entire design control process. Starting with the coordination of the technical feasibility activities, through design and development, until validation. During this process you will become the technical expert of the product.
For the existing products belonging to your domain, you will initiate change and improvement projects, follow-up on issues that can occur in various areas (e.g. production, customers, suppliers, …), coordinate the problem analysis and look for the appropriate solutions.
You will support marketing and plant management by providing necessary information (e.g. project information, test results, competitor information, …). Taking ownership of the products means that you will be the SPOC for the business unit: tackling technical questions from customers, review of product datasheets, drawing up product specifications for customers, ... You will ensure good communication towards project owners, internal customers, and plant management.
In your role, you will take ownership of the risk impact analysis and product validation protocols, including their practical implementation considering market demands and external requirements (e.g. ISO, FDA, …). You will report the results and maintain the risk management files.
You are responsible for the organization and maintenance of the required documentation related to the above activities, in line with the quality standards and systems of Terumo Europe. You will provide support during internal and external (customers, notified body, …) audits to explain and defend the procedures and documentation related to the topics above.