Mechanical Design Engineer, Consumables

Responsibilities

• Contribute to the mechanical design and development of consumable perfusion sets and packaging from concept to design transfer
• Develop mechanical architectures, specifications, technical requirements, DFMEAs, drawings, and Bills of Materials (BoMs)
• Define testing and validation for critical mechanical characteristics including functional performance, safety, and reliability
• Perform technical problem-solving, root-cause analysis, and risk-mitigation activities across the product lifecycle
• Maintain Design Development File (DDF) and Device Master Record (DMR) documentation in compliance with regulatory requirements
• Collaborate with cross-functional teams including Systems, Electronics, Software, Clinical, Quality, and Manufacturing
• Partner with external engineering consultants, suppliers, and manufacturing partners to ensure high-quality delivery

Requirements

• Bachelor’s or Master’s degree in Engineering, Biomedical Sciences, or a related field
• Proven experience designing plastic components, specifically for injection moulding and thermoforming
• Strong understanding of design controls, risk management, and verification methods
• Proficiency in CAD software and Document Management Systems (SolidWorks and PDM preferred)
• Experience working within the medical device industry or a similar highly regulated, safety-critical sector
• Excellent communication and organizational skills with the ability to manage multiple priorities

Preferred Qualifications

• Experience with packaging and transit simulation
• Knowledge of biocompatibility and sterilization processes
• Familiarity with industry standards such as FDA requirements, IEC 60601, ISO 13485, or ISO 10993

Benefits

• Competitive compensation and comprehensive benefits package
• Healthcare and retirement plans
• Support for work-life balance
• Opportunities for ongoing professional development

About the Company

OrganOx is a commercial-stage organ technology company dedicated to improving outcomes for patients with acute or chronic organ failure. A pioneer in normothermic machine perfusion (NMP), OrganOx is part of the Terumo Group and provides innovative solutions to keep donor organs in a metabolically active state, increasing the availability of organs for transplant.