Verification & Validation Engineer

Department Info

At Terumo’s Therapeutic Interventional Oncology (TIO) division, we aim to be a global leader in Interventional Oncology. We integrate advanced technologies, including radioembolization, chemoembolization, and ablation, to develop innovative treatments that improve patient outcomes.

Job Summary

We are seeking a Verification & Validation Engineer to focus on developing and optimizing neutron activation processes for holmium microspheres and conducting general V&V activities for medical devices. In this critical role, you will ensure that our products meet stringent regulatory standards and function as intended, contributing directly to their safety and effectiveness in the market. You’ll work closely with nuclear engineers, material scientists, and cross-functional teams, ensuring our processes meet the highest quality standards.

Job Responsibilities

Neutron Activation Process Development:

• Design and refine neutron activation processes for holmium microspheres.
• Collaborate with nuclear engineers and material scientists to meet safety and efficacy standards.
• Execute V&V protocols, ensuring all technical specifications are met.

Regulatory Compliance:

• Ensure all processes comply with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and applicable radiological safety standards.
• Conduct risk assessments and develop protocols to mitigate potential hazards.

Technical Documentation & Reporting:

• Prepare comprehensive validation reports and technical documentation, ensuring traceability and compliance.
• Present findings to internal teams and regulatory bodies.

Process Improvement:

• Identify opportunities to optimize neutron activation processes and validation protocols for efficiency and safety.

Medical Device Verification:

• Support verification activities to ensure devices meet functional, safety, and performance requirements.
• Participate in design validation to ensure alignment with product and user needs.

Profile Description

• Bachelor's or Master's degree in Biomedical Engineering, Nuclear Engineering, Material Science, Medical Physics, or related field.
• Preferably 2-5 years of experience in medical device development, focusing on process validation and verification.
• Proficiency with V&V tools and risk management processes.
• Experience with neutron activation or radioisotope production is highly desirable.
• Strong understanding of regulatory standards (ISO 13485, ISO 14971, FDA QSR).
• Excellent communication, problem-solving, and analytical skills.
• Familiarity with safety protocols for radioactive materials; Radiation Safety certification is a plus.
• Ability to work effectively in cross-functional and multicultural teams.

Offer

At Terumo, we offer more than just a job—it’s a chance to make a meaningful impact.

• Competitive Rewards: A salary and benefits package that recognizes your dedication.
• Growth Opportunities: A wide range of development opportunities to support your career.
• Work-Life Balance: Hybrid work options with flexibility between office and home-based work.
• Inclusive Environment: A respectful, diverse, and inclusive workplace where everyone can thrive.

Contact Person

Connect with Jarne Jans, our Talent Acquisition Business Partner for EMEA, and take the first step towards making a difference at Terumo!

Don’t forget to upload your CV and motivation letter in English when applying.

Your career at Terumo begins here—apply now!