R&D Scientist with a Physical Test and Verification Focus

Coloplast

Humlebaek, Denmark

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

Stepping into this hands-on role, you become one of our subject matter experts and a technical lead on testing and method validation in projects. Thus, you can look forward to collaborating with other project members, developing test methods, validating them, coordinating design verification, analyzing data, applying statistics and to ensure 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 labs.

More specifically, your key tasks include:

Based on requirements define the test strategy from early concept testing to manufacturing tests
Identify testing parameters, associated equipment, and requirements to complete the development of new test methods
Provide technical input with regards to testing for the development of products in compliance with design controls and project plans
Collaborate with Design, Manufacturing, and Quality teams to evaluate testability of requirements, and translate those requirements into relevant verification test methods
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
Support the creation and maintenance of relevant QMS documents
Perform 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 relevant degree in engineering
Experience working with testing, preferably in Medical Device product development
Good understanding of engineering concepts and principles, as well as good documentation practice (GDP)
Good understanding of materials as they relate to medical devices
Innovative with respect to developing product concepts and test methods
Good technical writing skills to communicate with development teams and develop test protocols, synthesize data, and test reports
Familiarity with statistical analysis
Acquaintance with FDA, ISO, ASTM, and EN Standards as they apply to medical devices
Familiarity with design control process and procedures, design inputs and outputs, verification and validation, and usability
Good understanding of Quality Management Systems and standard operating procedures

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