R&D Scientist – Medical Device Verification and Validation

Job title:

R&D Scientist – Medical Device Verification and Validation

Company:

Coloplast

Job description

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.“As one of our expert generalists on testing in a regulated industry, you’ll be instrumental in ensuring that all product requirements have an appropriate level of verification and the relevant test methods have the right level of validation, while also securing that our products are tested and documented in a sound and traceable manner.” – Majk Kruszewski, Director of Test Engineering.A growing team of specialistsJoining R&D at our HQ in Humlebæk, Denmark, you become part of a growing team of experts within our Test & Characterisation department. We are in charge of leading the design and documentation of our testing strategies and responsible for ensuring that those test strategies and methods are implemented at Coloplast sites around the world.“It is an incredibly supportive team, so you will have plenty of opportunity to collaborate with your peers. What is more, we are responsible for the Design Verification and Test Method Development and Validation process and are constantly working to improve it, giving you a lot of influence in your daily work,” Majk explains.From early-stage concepts to final product
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 the projects test strategy, collaborating with other project members, developing test methods, validating them, 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 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. We encourage both seniors and non-seniors to applyMoreover, 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
• Aware of design control process and procedures, design inputs and outputs, verification and validation.

Interested? If you would like to know more about the position, please contact Director of Test Engineering Majk Kruszewski at dkmkru@coloplast.com. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate is found.Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.Visit us on .Follow us on . Like us on .58726
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Expected salary

Location

Humlebæk, Hovedstaden

Job date

Sun, 23 Mar 2025 05:10:43 GMT

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