Product Engineer

About the Company

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. A spin-out from the University of Oxford and part of the Terumo Group, OrganOx is a pioneer in normothermic machine perfusion (NMP) with its flagship metra® platform.

Responsibilities

• Support implementation and verification of design changes on existing products to drive continuous improvement
• Resolve component obsolescence, manufacturing issues, or complaints in partnership with Operations and Quality teams
• Create assembly and test instructions for production and suppliers
• Support design reviews and design transfer activities alongside Product Development teams
• Conduct problem-solving efforts and root cause analysis for device performance issues
• Create and refine engineering documentation including Design History Files and Device Master Records
• Assist with prototyping efforts and bench testing

Requirements

• Experience in Product Engineering or Product Development, preferably in medical devices or highly regulated industries
• Experience with electro-mechanical devices and troubleshooting
• Ability to design and execute experimental test plans for electro-mechanical and fluid components
• Strong technical report writing skills
• Degree in Electronic, Mechanical, Biomedical, or general engineering
• Proven experience in a similar role

Preferred Qualifications

• Understanding of ISO 13485 Quality Management Systems
• Experience with risk management and design controls