Test Engineer (Medical Devices)

About the role

Coloplast is looking for a Test Engineer with solid knowledge of test methods, equipment and design verification for non‑electronic medical devices. You will join the R&D Product Development team at the headquarters in Humlebæk and help ensure that products meet premium quality standards and customer needs.

Key responsibilities

• Collaborate with Design, Manufacturing and Quality teams to translate requirements into test methods for design verification.
• Provide technical input for product development in line with design controls and project plans.
• Develop and maintain documentation for test‑method development and validation procedures.
• Identify and recommend upgrades or new equipment for testing and verification activities.
• Support design transfer to manufacturing sites and work closely with test laboratories.

Required profile

• Degree in engineering (biomedical, mechanical or material preferred).
• Experience with verification or validation in medical‑device product development.
• Good understanding of engineering concepts, design‑control processes and good documentation practice.
• Strong technical writing skills for test protocols, data synthesis and reporting.
• Familiarity with FDA, ISO, ASTM and EN standards applicable to medical devices.

Required skills

• Test‑method development and validation.
• Statistical analysis for test data.
• Knowledge of design verification processes.
• Understanding of FDA, ISO, ASTM and EN standards.