Mechanical Design Engineer (FEA)

ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary

The Mechanical Design Engineer (FEA Specialist) will be responsible for designing and developing mechanical components and assemblies for OrganOx products, with a strong emphasis on structural, thermal, and fluid Finite Element Analysis (FEA). The role will require collaboration with cross-functional teams to ensure designs meet performance, safety, and regulatory requirements.

This is a flexible on-site role based in Oxford, UK to ensure close collaboration with engineering, quality, and regulatory teams.

Major Responsibilities

Under direction from the Director, Electrical and Mechanical Engineering, the Mechanical Design Engineer will be responsible for:

• Designing mechanical components and assemblies for medical devices using CAD tools.
• Performing detailed FEA simulations (structural, thermal, and fluid) to validate designs before prototyping.
• Collaborating with manufacturing and suppliers to ensure designs are manufacturable and cost-effective.
• Supporting prototype builds, design verification, and validation activities.
• Preparing engineering documentation in accordance with ISO 13485 and other applicable standards.
• Providing input to risk management and design reviews.
• Adhering to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

Requirements:
Skills & Experience

• Demonstrable industrial mechanical design experience, with dedicated time spent in FEA-focused roles.
• Proficient in CAD design (SolidWorks preferred).
• Strong expertise in FEA using tools such as ANSYS or SolidWorks Simulation.
• Knowledge of materials, manufacturing processes, and mechanical testing.
• Experience working in regulated industries, preferably medical devices.
• Ability to interpret and apply relevant standards (e.g., ISO 13485, ISO 14971).

Qualifications

• Bachelor’s degree or higher in Mechanical Engineering or related field or equivalent experience
• Experience in the full product lifecycle from concept to production.
• Ability to travel up to 10% as required.

Benefits:
At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.