Biocompatibility Engineer - Medical Devices for Cancer Care

Elekta AB; Nederland; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

27 paid vacation days

Hybrid working

Travel allowance

Pension plan

Insurance discounts

Job summary

Elekta AB is seeking a Biocompatibility Engineer in Veenendaal, Netherlands, to join our R&D Brachytherapy team. You will blend systems engineering with biocompatibility expertise, shaping medical-device development across the product lifecycle.

Responsibilities include translating clinical needs into requirements, maintaining architectures, and guiding sterilization and reprocessing standards. A strong regulatory background and collaboration with cross-functional teams are essential.

Qualifications

• University degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biomedical/Biomechanical Engineering, Mechanical Engineering or similar.
• 5+ years of relevant experience in medical-device or regulated product development.
• Experience with systems engineering and design controls in medical devices.
• Knowledge of ISO 13485, ISO 14971, EU MDR and related standards is required.

Responsibilities

• Translate user and clinical needs into functional and technical requirements across Product Management and stakeholders.
• Define and maintain system architectures and engineering documentation throughout the product lifecycle.
• Lead risk management, requirements management, traceability, design reviews and verification/validation activities.
• Coach engineers on biocompatibility, sterilization and reprocessing practices and standards.
• Coordinate external laboratory testing and review test protocols and reports.
• Contribute to technology roadmaps and agile development within SAFe framework.

Skills

Biocompatibility

Systems engineering

Medical devices

Regulatory knowledge

Materials science

Project leadership

Education

University degree in Chemistry

Biomedical/Biomechanical Engineering

Tools

FTIR

Gas chromatography

Job description

Elekta AB is seeking a Biocompatibility Engineer in Veenendaal, Netherlands, to join our R&D Brachytherapy team. You will blend systems engineering with biocompatibility expertise, shaping medical-device development across the product lifecycle.

Responsibilities include translating clinical needs into requirements, maintaining architectures, and guiding sterilization and reprocessing standards. A strong regulatory background and collaboration with cross-functional teams are essential.