Product Change and Verification Engineer ( mechanical / chemical engineer )

We are recruiting for an international manufacturer of hight tech medical equipment.

The position

This is an involving and multi-facing leading role in which you use your engineering knowledge and documentation skills to pilot product improvements through the organization. You also participate in multidisciplinary teams to implement new products and innovations. For the design transfer and submission of new products you are responsible for collecting evidence to prove that all requirements have been met. All of this requires you to be a self-starter who is focused on getting the job done.

You are part of a young and informal team of seven engineers and you work closely together with people from various departments including Procurement, Regulatory Affairs, Quality Assurance, Manufacturing Engineering and Production.

This involves a number of detailed activities:
Translation of product requirements into functional and technical specifications;

Leading engineering change requests and product change requests effectively through the organization;

Preparation of design transfer documents for the Manufacturing Department and support for the validation of manufacturing processes.

You will have the following skills and capabilities
A central aspect of the role is to generate all necessary documentation including biological safety evaluation- and  sterilization validation reports, along with all necessary verification documents. In doing so you create an overview of all design aspects, production processes and all applicable standards in the mentioned documents. You should therefore be highly accurate, able to generate the protocols and reports from scratch having first acquired and analyzed all the necessary data in a statistical way. You also have the ability to guide engineering change orders (ECO) and product change requests (PCR) through the organization, together with the departments Regulatory Affairs, Quality Assurance and Manufacturing Engineering, keeping all parties informed and updated.

This is a complex task for a quality-focused and empathetic team player, who can work proactively with others to solve problems in the interests of cancer patients. Of course, you should be able to act on your own initiative when necessary, but you will always be able to call on the support of our experts.

We also ask you to bring:

Bachelor’s degree in Mechanical/Chemical engineering, ideally with a specialization in medical device development;
Three to five years of experience, perhaps in a Chemical or Regulatory Affairs role;
Experience with process validations and Biological Safety evaluation reports;
Experience with Enovia or a similar system, along with experience with 3D CAD systems (Solidworks, ProEngineer and/or Inventor);
Ideally you have experience with clinical applications, knowledge of modern product development processes and knowledge of MDD/MDR;
Strong writing, speaking and listening skills necessary to communicate effectively, in Dutch and English.

We offer
A competitive salary that matches your experience;
Profit-sharing arrangement: max 16% on a yearly basis (9% average in recent years);
8% holiday allowance;
27 vacation days and 13 ADV days per year;
Travel allowance for home-work travel;
Tax-advantageous fitness package;
Good company restaurant and regular opportunities to socialize within the company