Senior Mechanical Design Engineer - Consumables in Oxford

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). 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.

Position Summary

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.

Major Responsibilities

• 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 OrganOx's Code of Conduct and all relevant company policies.

Skills & Experience

• 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 skills and ability to manage multiple priorities with multiple parties in a fast‑paced environment.
• Experienced user of CAD software and Document Management Systems (SolidWorks and PDM preferable).
• Background in packaging and transit simulation, biocompatibility & sterilisation also desirable.
• Familiarity with relevant standards such as FDA requirements, IEC 60601, ISO 13485, ISO 10993 and others applicable to medical device design.

Qualifications

• Bachelor's or Master's degree in Engineering, Biomedical Sciences, or related field.
• Evidence of a solid track record of technical contributions within the medical device industry, preferably with Class II or III devices.

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.