Senior Test Engineer
A newly established team of specialists Joining R&D at our HQ in Humlebæk, Denmark, you become part of a newly established and still growing team of experts within our Test & Characterization department.
The Senior Test Engineer will be a core member of development teams, and responsible for extracting the early signs of a product requirement and translating that into a test environment. The testing support may start in early concept and will continue through into verification stages of a project. The Test Engineer will act as technical lead, providing support for interdepartmental development teams and projects to fulfill business goals of Coloplast for new products and line extensions.
Areas of Accountability:
- Provide technical input with regards to testing for the development of products in compliance with design controls and project plans
- Identify testing parameters, associated equipment, and requirements to complete the development of new methods
- Collaborate with R&D, Manufacturing, and Quality teams to evaluate testability of requirements, and translate those requirements into relevant verification test methods
- Lead the development and maintenance of documents for test method development, test method validation procedures, and equipment qualifications
- Obtain and maintain all necessary information and experimental test results related to assigned projects by various means of recording
- Analyze test anomalies and create test summary and report style technical documents
- Identify potential upgrades and new equipment for testing and verification activities
- Support the creation and maintenance of relevant QMS documents
- Hold a degree in engineering, e.g. within mechanics, physics, chemistry, or a similar discipline
- Bring 3+ years of experience working with Testing, preferably in Medical Device product development.
- Strong 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
- Strong technical writing skills to communicate with development teams and develop test protocols, synthesize data, and test reports
- Familiarity with statistical analysis
- Familiarity 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
As you will be a main contributor to projects, it is vital that you thrive in a project-based environment. You know how to navigate a diverse stakeholder landscape, and how to coordinate and facilitate tasks that span quality and regulatory requirements as well as multi-disciplinary technical teams.
Knowledge, Skills and Abilities:
- Ability to work independently and to be a technical lead
- Good written and verbal communication
- Able to work cooperatively and be a team player
- Pro-active; high-performer and results oriented
If you would like to know more about the position, please contact Head of Test Engineering Mikael Kruszewski at firstname.lastname@example.org. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.
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