Test Engineer

Test Engineer

Coloplast

Humlebæk, Denmark

Do you have knowledge of Test Method Development and Design Verification for Medical Devices? And would you like to help ensure that our products not only meet the requirements but are premium quality and fulfill our customers’ needs?

Then grab this opportunity to join one of the best-performing medical device companies in the world and help make a difference for people with intimate health care needs across the globe.  

Stepping into this hands-on role, you become one of our subject matter experts on verification and validation in projects. Thus, you can look forward to setting up a project test strategy, collaborating with other project members, developing test methods, validating them, analyzing data, applying statistics and ensuring that the output from our tests meets our design requirements.  

Doing so, you will be working closely with various stakeholders throughout the product design and development process and with our test laboratories. 

 More specifically, your key tasks include:

• Based on requirements, creating test methods from early concept testing to manufacturing tests;
• Identify testing parameters, associated equipment, and requirements to complete the development of new test methods;
• Collaborate with Design, Manufacturing, and Quality teams to evaluate the testability of requirements, and translate those requirements into relevant test methods;
• Provide technical input with regards to testing for the development of products in compliance with design controls and project plans;
• Contribute to development and maintenance of documents for test method development and test method validation procedures;
• Identify potential upgrades and new equipment for testing and verification activities;
• Assist Design Transfer to manufacturing sites.

It is vital that you thrive in a project-based environment. You know how to navigate a diverse stakeholder landscape and coordinate and facilitate tasks that span quality and regulatory requirements and multi-disciplinary technical disciplines.

Moreover, you:

• Hold a degree in engineering, preferably biomedical, mechanical or material;
• Have experience working with Verification or Validation in medical device product development;
• Understanding of engineering concepts and principles, as well as good documentation practice (GDP);
• Innovative with respect to developing product concepts and test methods;
• Strong technical writing skills to communicate with development teams and develop test protocols, synthesize data, and test reports;
• Understanding of statistical analysis;
• Awareness of FDA, ISO, ASTM, and EN Standards as they apply to medical devices;
• Have a good understanding of design control process and procedures, design inputs and outputs, verification and validation.