Mechanical Design Engineer, Consumables

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).  It's 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. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil 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.

Position Summary

The Mechanical Design Engineer, Consumables is a hands-on role responsible for supporting 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 on-site position 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.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Major Responsibilities

Under direction from the Mechanical Engineering Manager, Consumables, the Mechanical Design Engineer, Consumables will be responsible for:

Technical Contribution

• Contribute to the mechanical design and development activities for consumable perfusion sets and packaging, supporting activities from concept through to design transfer.
• Supporting the development of mechanical architectures, specifications, technical requirements, DFMEAs (Design Failure Mode and Effects Analysis), drawings, BoMs (Bill of Materials) and related documentation.
• Assist with defining testing and validating critical mechanical characteristics including functional performance, safety, reliability and interface integrity.
• Contribute significantly to technical problem-solving, root-cause analysis and risk-mitigation activities across the product lifecycle.
• Contributing to Design Development File (previously known as a DHF) and Device Master Record (DMR) documentation, in line with regulatory and quality requirements.

Collaboration & Cross-Functional Support

• Effective collaboration with cross-functional teams including System Engineering, Mechanical, Electronics, Software, Clinical, Quality, Regulatory, Operations and Manufacturing.
• Provide well-qualified technical input to project plans, design reviews, verification/validation activities and regulatory submissions.
• Support effective engagement and partnership with external engineering consultants, suppliers and manufacturing partners to ensure high-quality delivery of outsourced work.
• Communicate effectively across teams to enable and support timely and efficient product development.

Continuous Improvement & Knowledge Development

• Seek out and identify development opportunities aligned to role requirements and personal growth goals.
• Proactively keep informed with relevant technological advancements, materials, manufacturing approaches, sterilisation techniques and medical device standards.
• Support development, qualification and maintenance of mechanical engineering tools, systems and methodologies.
• Proactively share knowledge with peers and provide informal support to junior team members, where appropriate.
• Actively contribute to the continuous improvement of SOPs, work instructions and engineering processes. 

Documentation & Compliance

• Prepare and contribute to DDF documentation, including design inputs, risk assessments, test protocols and reports.
• Support audits, inspections and regulatory submissions with high-quality technical input.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Skills & Experience

• Proven experience of contributing to the design of plastic components, particularly for injection moulding and thermoforming, from concept through to verification and design transfer.
• Demonstrate an understanding of design controls, risk management, verification methods and mechanical engineering best practices.
• Able to evidence effective collaboration with external design agencies and/or manufacturing partners.
• Strong communication skills with a collaborative, problem-solving mindset.
• Excellent organisation skills and the ability to manage multiple priorities in a fast-paced environment.
• Proficient and experienced user of CAD software and Document Management Systems (SolidWorks and PDM preferable).
• Packaging and transit simulation experience, as well as biocompatibility & sterilisation is desirable.
• Familiarity and working knowledge of working to industry standards. Ideally standards such as FDA requirements, IEC 60601, ISO 13485, ISO 10993 but adjacent industry standards will be considered.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Biomedical Sciences, or related field.
• Proven track record of related engineering work experience. Will accept operational experience in a similar field.
• Demonstratable experience contributing to technical projects, within the medical device industry, or similar safety-critical and highly regulated sector.

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.