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Oxford, Oxfordshire, United Kingdom OrganOx Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Devices R&D Engineer to join our Product Engineering team at OrganOx. As a key member of our team, you will be responsible for leading design changes to support product, production, and quality improvements.Key ResponsibilitiesLead root cause analyses of field performance issues and manage...
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Oxford, Oxfordshire, United Kingdom OrganOx Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Devices R&D Engineer to join our Product Engineering team at OrganOx. As a key member of our team, you will be responsible for leading design changes to support product, production, and quality improvements.Key ResponsibilitiesLead root cause analyses of field performance issues and manage...
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Senior Medical Devices R&D Engineer
2 months ago
We are seeking a highly skilled Senior Medical Devices R&D Engineer to join our Product Engineering team at OrganOx. As a key member of our team, you will be responsible for leading design changes to support product, production, and quality improvements.
Main Responsibilities:
- Conducting problem-solving efforts and root cause analysis to identify design changes driven by component obsolescence or supply chain.
- Investigating device performance issues, determining, and reporting the root cause, 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.
- Assisting 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:
- 5+ years' experience within Research and 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 electronic, mechanical, or 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.
About OrganOx:
We recruit and retain the best people from a broad range of diverse backgrounds who share our values of innovation, evidence, integrity, teamwork, respect, and passion. If you're looking for a challenging and rewarding role in a dynamic team, we encourage you to apply.
