Senior Biocompatibility Engineer – Medical Devices

Elekta AB; Veenendaal; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Vacation days (27) & ATV days

Global bonus plan

Travel allowance

Pension plan with BeFrank

Insurance discounts

Active staff association

Tax benefits for fitness

Job summary

Elekta AB in the Netherlands is seeking an experienced R&D Engineer for Brachytherapy to develop and sustain medical devices used in cancer treatment. You will translate clinical needs into robust requirements and guide systems engineering across the product lifecycle, ensuring regulatory compliance and high-quality documentation.

The role demands 5+ years in medical-device development, strong materials and biocompatibility knowledge, and collaboration with QA, RA, and manufacturing teams.

Qualifications

• University degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biomedical/Biomechanical Engineering, Mechanical Engineering, or equivalent.
• 5+ years of relevant medical-device or regulated product development experience.
• Experience with systems engineering and medical-device design controls (requirements mgmt, traceability, risk, validation).

Responsibilities

• Translate user and clinical needs into clear requirements with stakeholders.
• Define and maintain system architectures and engineering docs across product lifecycle.
• Lead activities: requirements management, traceability, design reviews, risk mgmt, verification, validation.
• Guide development through feasibility, concept development, testing strategies, new tech.
• Act as SME for biocompatibility, safety, sterilization, reprocessing; coach others.
• Create and maintain Design & Development Files, risk docs, and regulatory evidence.
• Coordinate product testing with external labs; review protocols and reports.
• Investigate customer issues via root-cause analysis and engineering rationale.
• Apply materials and manufacturing knowledge to device design and industrialization.
• Define work packages, effort estimates, deliverables, and timelines.
• Contribute to roadmaps, innovations, and evaluation of new technologies.
• Provide guidance and knowledge sharing across Brachy Solutions.
• Collaborate with Supply Chain, RA/QA and cross-functional teams during audits and post-market work.
• Participate in SAFe Agile development; take tech leadership roles when appropriate.

Skills

Fluent English

Systems engineering

Analytical thinking

Collaborative mindset

Agile development

Education

University degree in chemistry/engineering or comparable science

Job description

Elekta AB in the Netherlands is seeking an experienced R&D Engineer for Brachytherapy to develop and sustain medical devices used in cancer treatment. You will translate clinical needs into robust requirements and guide systems engineering across the product lifecycle, ensuring regulatory compliance and high-quality documentation.

The role demands 5+ years in medical-device development, strong materials and biocompatibility knowledge, and collaboration with QA, RA, and manufacturing teams.