Senior Mechanical Design Engineer

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. 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.

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 (QMS). This is an onsite role based in Oxford with flexibility, working as part of the Consumables Mechanical Engineering team, collaborating closely with internal stakeholders and external customers, suppliers, manufacturers and test houses, as required.

Major Responsibilities:

• Leading mechanical design and development activities for consumable perfusion sets and packaging contributing expertise from concept through to design transfer.
• Developing and maturing mechanical architectures, specifications, technical requirements, DFMEAs (Design Failure Mode and Effects Analysis), drawings, BoMs (Bill of Materials) and related documentation.
• Defining, testing and validating critical mechanical characteristics including functional performance, safety, reliability and interface integrity.
• Driving technical problem-solving, root-cause analysis and risk-mitigation activities across the product lifecycle.
• Contributing to Design History File (DHF) and Device Master Record (DMR) documentation, in line with regulatory and quality requirements.

Collaboration & Cross-Functional Support:

• Collaborating with cross-functional teams including Systems Engineering, Electronics, Software, Clinical, Quality, Regulatory, Operations and Manufacturing.
• Contributing 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 relationships are built and maintained and the delivery of outsourced work is to the desired quality.
• Act as the focal point for consumable set development, using organisational and communication skills effectively across all interfacing parties, to ensure effective delivery.

Continuous Improvement & Knowledge Development:

• With support, identify skills gaps and set improvement goals aligned to the job need and personal progression goals.
• Stay current with relevant technological advancements, materials, manufacturing approaches, sterilization methods and medical device standards.
• Supporting the development, qualification and maintenance of mechanical engineering tools, systems, and methodologies.
• Providing mentorship, guidance and technical insight to Junior Engineers without formal line-management responsibility.
• Contributing to the refinement of SOPs (Standard Operating Procedures), work instructions, and engineering processes that support effective mechanical engineering.

Documentation & Compliance:

• Preparing and contributing to Design History File (DHF), with documents such as design inputs, risk assessments, test protocols and test reports.
• Supporting audits, inspections and regulatory submissions with high-quality technical evidence and presentation of engineering rationale.
• Ensuring adherence to OrganOx's Code of Conduct and all relevant company policies.

Requirements:

• Experience in 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 organisation skills and the 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.
• Able to evidence 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.