Test Engineer

Coloplast; Humlebæk; On-site; DKK 650,000 - 800,000; Full time

Job summary

Coloplast in Humlebæk, Denmark, is seeking a verification/validation expert for medical devices to lead test strategy development and ensure methods meet design requirements. You’ll collaborate across Design, Manufacturing and Quality and work with our test laboratories.

Role emphasizes GDP, statistical analysis, and strong technical writing to develop protocols, validate tests, and support design transfers in a global medical devices environment.

Qualifications

• Hold a degree in engineering, preferably biomedical, mechanical or material.
• Experience with Verification or Validation in medical device product development.
• Understanding of engineering concepts and principles and GDP.
• Knowledge of statistical analysis.
• Strong technical writing skills for test protocols and reports.
• Awareness of FDA, ISO, ASTM and EN standards.

Responsibilities

• Collaborate with Design, Manufacturing and Quality to translate requirements into test methods for Design Verification.
• Provide input on testing for development of products in compliance with design controls.
• Develop and maintain documents for test method development and validation procedures.
• Identify potential upgrades and new equipment for testing and verification activities.
• Assist Design Transfer to manufacturing sites.

Skills

Biomedical engineering

Mechanical engineering

Material engineering

Verification & Validation

GDP

Statistical analysis

Technical writing

Education

Engineering degree (biomedical/mechanical/material)

Job description

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Do you have knowledge of Test Methods, equipment and Design Verification for non-electronic 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.

A growing team of specialists

Joining R&D at our HQ in Humlebæk, Denmark, you become part of a growing team of experts within R&D Product Development. 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, Test Methods & Test Method Validation, and are constantly working to improve it, giving you a lot of influence in the daily work,” – Simon, Head of Systems & Test Engineering.

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 a project test strategy, collaborating with other project members, working with 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:

• Collaborate with Design, Manufacturing, and Quality teams to evaluate the testability of requirements, and translate those requirements into relevant test methods for Design Verification.
• 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

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.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark