As our Product Engineer, you will initiate the modification sheet to handle Change Control projects and play a primary role in coordinating actions with various departments (business unit, Production, Regulatory Affairs, Process Validation, Quality, ...) and properly document everything. In addition, you introduce and support in consultation with various departments and through the analysis of product performance parameters, new products, process adjustments or product improvements, in line with internal and external standards.
You carry out technical research, look for a solution and follow up on problems that can occur in the various operating areas (Production, customers, Suppliers) and this for the products belonging to your domain.
By fulfilling your role, you will develop Risk Impact Analyses and product validation protocols and take care of their practical implementation. This considers for example market demands and external requirements (ISO, FDA…). Additionally, you will report the results in the product validation report and maintain the risk management files.
You provide support towards the marketing manager (BU) and Plant Management by providing project information, research results, and competition research for the products belonging to your domain. You will be a SPOC for the business unit, concerning technical questions from customers, review of product datasheets, drawing up product specifications for customers, ....
You coordinate the research into the technical feasibility of new products at the request of the market. You may be in the coordination of problem analysis, improvement projects, introduction projects, in which you supervise the work and also conduct your own tasks. As Product engineer you are responsible for respecting the timing, the budget, as well as the safety and quality regulations that have been set. You will also ensure a good communication towards project owners, internal customers and the Plant management.
You are responsible for organizing and maintaining a documentation system in relation to the above activities and this in line with the quality standards and systems of Terumo Europe.
You provide support during internal and external (customers, notified body, …) audits to explain and defend the procedures and documentation related to the topics above.