Biocompatibility & Systems Engineer

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We don’t just build technology. We build hope for everyone dealing with Cancer.

Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com.

What You’ll Do At Elekta

Join our R&D Brachytherapy team in Veenendaal and play a key engineering role in the development and lifecycle of medical devices that support cancer treatment.

This position combines Systems Engineering with subject matter expertise in biocompatibility, with a primary focus on Brachytherapy applicators. You will work across the full product lifecycle, translating clinical and customer needs into robust engineering requirements and architectures while ensuring our products meet demanding safety, quality and regulatory standards.

You will collaborate closely with mechanical and development engineers, Product Management, Application Specialists, Service, Supply Chain, Project Management and RA/QA. As our Subject Matter Expert, you will also guide teams on biocompatibility, biological safety, sterilization and reprocessing.

This is an opportunity for an engineer who enjoys working at the intersection of mechanical systems, materials, chemistry and medical-device development, and who wants to see their engineering decisions translate into solutions used in cancer care.

Responsibilities

• Translate user, customer and clinical needs into clear functional, system and technical requirements in collaboration with Product Management, Application Specialists, users, Service Engineers and other stakeholders.
• Define, maintain and continuously improve system architectures and associated engineering documentation throughout the product lifecycle.
• Drive systems engineering activities including requirements management, traceability, design reviews, risk management, verification, validation and change impact assessments.
• Guide product development through feasibility studies, concept development, engineering analyses, testing strategies and implementation of new technologies.
• Act as the Subject Matter Expert for biocompatibility, biological safety, sterilization and reprocessing, and coach development engineers on relevant engineering practices and standards.
• Develop and maintain technical documentation including Design & Development Files, Biological Safety Evaluations, risk management documentation and technical evidence supporting regulatory submissions.
• Coordinate product testing and analyses performed by external laboratories, including reviewing test protocols, monitoring progress and assessing final reports.
• Support investigation of customer complaints and technical issues through root cause analysis, calculations, engineering rationales and improvement proposals.
• Apply your knowledge of materials and manufacturing processes to the design and industrialization of medical devices and applicators.
• Define engineering work packages, effort estimates, technical deliverables and timelines for development activities.
• Contribute to technology roadmaps, innovation initiatives, concept explorations and evaluation of emerging technologies for Brachytherapy.
• Provide technical guidance and coaching to engineering colleagues and contribute to knowledge sharing across Brachy Solutions.
• Collaborate with Supply Chain, Project Management, RA/QA and customer-facing teams during development projects, audits, regulatory activities and post-market support.
• Participate in agile development within the SAFe framework and, where appropriate, take technical leadership responsibilities such as Product Owner, Scrum Master or Technical Lead.

What You’ll Bring

• A university degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biomedical/Biomechanical Engineering, Mechanical Engineering, or a comparable engineering or scientific discipline.
• At least 5 years of relevant experience in medical-device or regulated product development.
• A strong background in chemical engineering, materials science or biocompatibility combined with experience of hardware, manufacturing processes and mechanical products, or a mechanical/hardware engineering background complemented by proven expertise in chemicals, materials and biocompatibility.
• Experience with systems engineering and medical-device design controls, including requirements management, traceability, design reviews, risk management, verification, validation and change impact assessment.
• Strong knowledge of engineering materials such as plastics and metals, mechanical components, prototyping and manufacturing technologies suitable for medical devices.
• Experience with Biological Safety Evaluations, including Toxicological Risk Assessments, chemical characterization and reprocessing documentation.
• Experience coordinating outsourced laboratory testing, for example biocompatibility testing, FTIR or gas chromatography.
• Good understanding of relevant medical-device regulations and standards, such as ISO 13485, ISO 14971, EU MDR, IEC 60601 and ISO 10993, together with standards and methods relating to cleaning, disinfection, sterilization, bioburden, BET/LAL testing, packaging and sterile barrier systems.
• Strong analytical and structured problem-solving skills, with a pragmatic and solution-focused approach.
• A proactive and collaborative working style, with a commitment to quality and continuous improvement.
• Ability to work effectively in both structured and agile product-development environments.
• Fluent English. Dutch language skills are an advantage, as is a willingness to learn Dutch.

What You’ll Get

In this role, you will work for a higher purpose: hope for everyone dealing with cancer and access to the best cancer care for everyone, regardless of where they are in the world. You will be part of our international, innovative team, with opportunities to learn, develop and grow.

An overview of some of our benefits for Veenendaal is provided below:

• 27 paid vacation days per year, plus 13 ATV days.
• Global bonus plan.
• Travel allowance.
• Metalektro pension fund, with contributions shared 50/50, supplemented by an additional pension plan with BeFrank for pensionable income above the applicable threshold.
• Insurance discounts.
• Active staff association.
• Tax benefits for fitness-centre memberships and bicycle purchases.
• Hybrid working, with at least four days per week on location.

Application process

We look forward to receiving your application. Please submit your CV and motivation in Dutch (or English) via the “Apply” button. We review applications on an ongoing basis, so we encourage you to apply as soon as possible.

We are an equal opportunity employer. We evaluate qualified applicants without regard to age, race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.