ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally. As a result of our continued expansion, we are seeking a motivated Mechanical Engineer to join our Oxford based mechanical engineering team in the development of our next generation of innovative, transportable perfusion devices from concept to commercialisation.

POSITION SUMMARY

The Mechanical Engineer will work within a small multi-disciplinary team of engineers, including electronics, biomedical and software.
As part of product realization, the Mechanical Engineer will support design activities to develop and refine features, components and assemblies through a rigorous approach of analysis and test. The candidate’s experience should include risk management, tolerance analysis, details structural analysis inclusive of FEA, DFX and in the development of test methods and protocols. The candidate will create, control and maintain detailed CAD assemblies, parts and drawings therefore experience in SOLIDWORKS (or equivalent) and PDM is essential. Previous experience in medical devices under ISO 13485 is also advantageous.
The OrganOx system contains a retained unit and a single-use sterile, disposable set. Both systems use components from external suppliers and the role will require collaboration and management of suppliers to ensure that design requirements are well specified and that designs meet these specifications. Previous experience in design transfer to manufacturing is desirable as is knowledge of material compatibility, RIM moulding, Injection Moulding and electronics integration.
The candidate requires excellent written and verbal communication skills to document their activities in line with the company Quality Management System, planning and reporting on their work to a standard suitable for review by regulatory authorities.
This is an on-site role in Oxford with flexibility.
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.

SKILLS & EXPERIENCE

• Proven track record in the mechanical design and development of complex devices, preferably within medical devices or another highly regulated industry.
• Strong knowledge of mechanical engineering principles, materials and manufacturing processes.
• Proficiency in CAD software (preferably Solidworks).
• Familiarity with the regulatory requirements for medical devices for compliance with European, Canadian and United States quality standards, with practical working knowledge of applicable standards (desirable).
• Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English.
• Experience interacting with customers to gain feedback and assess product needs
• Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team.
• Ability to work effectively with outside suppliers and manufacturers.

QUALIFICATIONS

• A degree or equivalent qualification/experience in mechanical engineering, or other relevant discipline.
• 5+ years experience as a mechanical engineer preferably within the medical device industry or other regulated sector

Under direction from the Director, Electrical & Mechanical Engineering the Mechanical Engineer will be responsible for:

• Part of a team developing the mechanical design of OrganOx’s new products and its sub-systems

• • Creation and evaluation of designs for the device structure (frame & cladding).
• Creation and evaluation of designs for complex active medical devices sub- assemblies (heaters, injectors pumps & valves).
• Ensuring designs are robust, well-evaluated and capable of withstanding the lifetime requirements of large transportable electromechanical devices.
• Informing of testing programs to aid in evaluation of designs with respect to standardised testing.
• Ensuring compliance with design and development procedures and ensuring all associated documentation is complete in accordance with company QMS and local procedures, including:
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• Ensuring the designs are compliant with applicable medical device standards.

• Ensuring specification drawings and documents are controlled.
• Creation of technical documentation required under the regulatory frameworks and standards for medical devices in UK, Europe, Canada and the United States.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies