Senior Mechanical Design Engineer - Consumables

About Organ Ox

Organ Ox 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. Organ Ox is a pioneer in normothermic machine perfusion (NMP). Its flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia and has been utilized in over 7,000 liver transplants to date, keeping donor livers in a metabolically active state outside the body to enable longer preservation times and functional assessment of the organ prior to 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.

The Senior Mechanical Design Engineer (Consumables) role is a hands‑on engineering position leading the design, development, verification and transfer of the next‑generation class III consumable perfusion. The role works within a cross‑functional R&D environment and operates under an ISO 13485, 21 CFR Part 820 and MDR (Medical Device Regulation) quality management system. This onsite role is based in Oxford and requires collaboration with internal stakeholders, external customers, suppliers, manufacturers and test houses.

• Technical Ownership
  • Lead mechanical design and development activities for consumable perfusion sets and packaging from concept through design transfer.
  • Develop and mature mechanical architectures, specifications, technical requirements, DFMEAs, drawings, BoMs and related documentation.
  • Define, test and validate critical mechanical characteristics including functional performance, safety, reliability and interface integrity.
  • Drive technical problem‑solving, root‑cause analysis and risk‑mitigation activities across the product lifecycle.
  • Contribute to Design History File (DHF) and Device Master Record (DMR) documentation in line with regulatory and quality requirements.
• Collaboration & Cross‑Functional Support
  • Collaborate with cross‑functional teams including Systems Engineering, Electronics, Software, Clinical, Quality, Regulatory, Operations and Manufacturing.
  • Contribute technical input to project plans, design reviews, verification/validation activities and regulatory submissions.
  • Lead packages of work with external engineering consultancies, suppliers and manufacturing partners, ensuring quality delivery of outsourced work.
  • Act as focal point for consumable set development, using organisational and communication skills to ensure effective delivery.
• Continuous Improvement & Knowledge Development
  • Identify skills gaps and set improvement goals aligned to the job need and personal progression.
  • Maintain awareness of technological advancements, materials, manufacturing approaches, sterilisation methods and medical device standards.
  • Support the development, qualification and maintenance of mechanical engineering tools, systems and methodologies.
  • Provide mentorship, guidance and technical insight to Junior Engineers.
  • Contribute to SOP refinement, work instructions and engineering processes to support effective mechanical engineering.
• Documentation & Compliance
  • Prepare and contribute to DHF with design inputs, risk assessments, test protocols and reports.
  • Support audits, inspections and regulatory submissions with high‑quality technical evidence.
  • Ensure adherence to Organ Ox's Code of Conduct and all relevant company policies.

• Experience leading the design of plastic components, mainly for injection moulding and thermoforming, from concept through verification to design transfer.
• Strong understanding of design controls, risk management, verification methods and mechanical engineering best practices.
• Proven track record of collaborating with external design agencies and manufacturing partners.
• Strong communication skills with a collaborative, problem‑solving mindset.
• Excellent organisational…