Mechanical Design Engineer, Consumables

About the role

OrganOx is seeking a hands‑on Mechanical Design Engineer to support the design, development, verification and transfer of next‑generation Class III consumable perfusion sets. The role is based on‑site in Oxford and works within a cross‑functional R&D team under an ISO 13485, 21 CFR Part 820 and MDR quality management system.

Key responsibilities

• Contribute to mechanical design and development of consumable perfusion sets and packaging from concept through design transfer.
• Develop mechanical architectures, specifications, technical requirements, DFMEAs, drawings, and Bills of Materials.
• Define and execute testing to validate functional performance, safety, reliability and interface integrity.
• Perform root‑cause analysis, risk mitigation and technical problem‑solving across the product lifecycle.
• Prepare and maintain Design Development File (DHF) and Device Master Record (DMR) documentation in line with regulatory and quality requirements.
• Collaborate with system engineering, electronics, software, suppliers, manufacturers and test houses.

Required profile

Required skills

• Mechanical design and development for medical devices
• Design Failure Mode and Effects Analysis (DFMEA)
• Creation of drawings and Bills of Materials (BoM)
• Knowledge of ISO 13485, 21 CFR Part 820 and Medical Device Regulation (MDR)
• Root‑cause analysis and risk‑mitigation techniques

What we offer

• Opportunity to work on cutting‑edge organ perfusion technology
• Collaboration with a multidisciplinary R&D team
• On‑site role in Oxford with flexible working arrangements