Medical Device Test Engineer: Verification & Validation

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

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.