As a Product Engineer you are responsible for the existing and future products within your domain. You play a coordinating role in the change control of existing products, as well as the development, implementation, and validation of new products. During this process you will create and/or compile the related documents. You will analyse both your own products and the products of the competitors with the aim of initiating, developing, and testing product improvements as well as ensuring compliance with internal and external (including ISO) standards.
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.
You are in possession of a Master's degree in an engineering or a scientific field (e.g. (bio)chemistry, physics, civil engineering, bio-engineering, biomedical, ...).
You have a first work experience in a similar position such as Product Engineer, Development Engineer or Design Engineer, within the medical device industry. You have experience in change and/or design control for existing and new products.
Being knowledgeable in plastic or injection moulding will be regarded as an asset.
You are fluent in English. This entails both the verbal and written skills. Proficiency in Dutch is a bonus.
You have a strong eye for detail and a can-do attitude. You like to deal with problems or new tasks, and dislike to give up until you've found the solution.
You are communicatively strong, stress resistant and accurate. In addition, you possess good project management skills.
Working for Terumo means contributing to society through healthcare.
Terumo offers an attractive salary and benefits package. We offer an opportunity to work in a top performing team. An organisation where everyone is treated with respect. We strive to create a diverse, equal and inclusive work environment. We invest in our associates by offering a broad array of development opportunities.
Linked with our core value Care, Terumo allows a hybrid way of working, combining office with home-based work. For this role this means office first, but you have the possibility to work from home on a regular basis.
During your recruitment process, you will be able to have conversations with Klaas De Greve as the hiring manager and other passionate Terumo associates.
Interested in using your skills to support our passionate team?