Product Engineer

Position Summary

OrganOx is in the process of expanding its engineering capability and is seeking an enthusiastic Product Engineer to join the Product Engineering team. As part of a small multi-disciplinary Product Engineering team, the successful candidate will have responsibility for activities focused on the existing product range in the following areas:

• Support the implementation and verification of design changes on the existing product range, to introduce new features and functionality and drive continuous improvement
• Work closely with the operations team in resolving component obsolescence, manufacturing issues, or complaints on the existing OrganOx product.
• This will require close partnership with field-based Customer service, Operations, and Quality teams
• Supporting the creation of assembly and test instructions required by the Operations team and suppliers, to ensure the transfer of designs to production are delivered in accordance with design change and operational SOPs
• Working closely with Product Development and Innovations teams throughout development projects with a focus on supporting design reviews and design transfer activities

Major Responsibilities

• Contributing to design changes to support product, production and quality improvements. This includes conducting problem-solving efforts and root cause analysis
• Investigating device performance issues, determining, and reporting the root cause (in collaboration with the quality, service and operations departments), and recommending corrective actions
• Interpreting and understanding the product's intended use, clinical procedures, customer needs and design inputs
• Creating and/or refining engineering documentation, such as the Design History File and the Device Master Record
• Following, learning, and contributing to R&D procedures, such as failure analysis, design controls and risk management, per the Quality Management System
• Aiding prototyping efforts and bench testing
• Preparing reports and conclusions for presentation
• Ensuring compliance with design and development procedures and ensuring all associated documentation is complete in accordance with ISO 13485 and local procedures

Requirements

• Demonstrable experience within Product Engineering/Product Development, preferably within medical devices or another highly regulated industry
• Experience with electro-mechanical devices, with understanding of how to drive, interface with and troubleshoot devices
• Ability to design, implement and carry out experimental test plans for electro-mechanical, fluid components, sub-systems, and complete safety-critical systems
• Ability to produce technical reports to a high standard both in terms of technical content, presentation, and written English
• Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team
• Ability to work effectively with outside suppliers and manufacturers
• Ability to work across and manage a range of projects or tasks simultaneously

Qualifications

• Essential: A degree or equivalent qualification/experience in Electronic, Mechanical, Biomedical, or general engineering, or other relevant disciplines
• Demonstrable years of experience of working in a similar role