test engineer medical devices to Vigmed in Helsingborg

Job description
Here is an opportunity to come join Vigmed, a Med Tech company in an exciting phase! Vigmed provides health care professionals with automatic safety I.V. and arterial catheters for safe and successful insertion. As a Test engineer you will ensure that the best processes for testing our products in development as well as in manufacturing are implemented. You will play an important role to secure that our products meet set requirements. Vigmed is a small company, part of Greiner Bio-One (GBO) which is a large privately held Austrian Med Tech company with more than 2000 employees around the world. Do you have an open and straightforward mind-set and want to work with ambitious and dedicated colleagues? Then maybe you are the one we are looking for!

Responsibilities
You will be responsible for all aspects related to testing designs, including planning, conducting and reporting verification and validation testing. The testing consists mostly of mechanical testing and dimensional measurements. An important part is to document testing as required for Medical devices. In early product development phases, you will also play an important role performing bench tests, help defining design requirements and sharing your knowledge in optimal design with the development team. Furthermore, you will perform tests where it is needed prior to release of production batches.

Some of the tests are also done externally, and in those cases you are responsible for ensuring that they are ordered and executed and that the tests are done according to regulatory requirements. 

Other tasks included in this role are;
• Ensure that all test methods are validated and maintained, including that all equipment which is needed for design verification and release, is calibrated.
• Create design verification test plans, or ensure that they are created, including defining sample sizes.
• Support engineering team with root cause analysis, for problems identified during verification testing.
• Support organization with root cause analysis, for problems identified e.g. in a complaint or in the production.

Working hours
Permanent position.

Qualifications
You have a B.Sc. in Mechanical Engineering or similar and are fluent in English, both spoken and written. To succeed in this role, you need to have a few years of experience working with mechanical tests and measurements of medical devices, or within other regulated industry. You also need to have a few years of experience working according to ISO13485 or ISO17025 requirements. In addition to this you have worked at few years with verification and validation documentation, such as writing test protocols and test reports (in English). Your understanding of mechanical design and materials (plastic and metal) is good. 

Following skills are preferred, but not mandatory;
• Six Sigma Green Belt education
• Knowledge about biocompatibility study according to ISO10993 or USP Class VI
• Experience of working with statistics for usage in handling test data.
• Fluent in Swedish, Danish or Norwegian 

We are looking for a driven person who is structured and meticulous. To be the right person for this role, it is important that you have the ability to work both independently and in teams. You are a problem solver who works proactively to develop new test methods and you can identify new equipment in order to enhance the laboratory's capabilities. We want you to have an interest in collaborating with other laboratories at GBO, as well as with external laboratories, to share and develop working methods.

If you feel that your professional and personal skills fit into the description, please send your application and come join Vigmed!

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
Last day for application is 2021-02-14.

More information: Randstad Life Sciences will manage this recruitment. For more information about this position, please contact Recruitment Consultant Emelie Lanner 072-9733382 or emelie.lanner@randstad.se. Please send your application in English via www.randstad.se.

We look forward to your application!

About the company
Vigmed is a company within medical devices. We are situated in Helsingborg with a mission to eliminate needle stick injuries within healthcare during intravenous and arterial catherization. Our philosophy when developing the first range of products was to provide the health care workers with familiar, high quality, affordable products, which provide increased protection from needle sticks. Today, we have marketed products for intravenous and arterial catheterization first launched in 2014 – all with an automatic safety function built-in. We have launched the products in all of Western Europe and selected markets outside Western Europe. Our short-term focus is to establish ourselves in the market with existing or upgraded products, and long term to innovate and launch even better solutions than what is present in the market today.  

During 2017, Vigmed became part of Greiner Bio-One (GBO), which is a privately held, Austrian company within the Med Tech industry. Combining the innovative capabilities and “center of excellence” knowledge within Vigmed with GBOs market position and financial strength is expected to accelerate our growth even further.