Graduate / Junior Medical Devices Engineer (Iso13485)

Graduate / Junior Medical Devices Engineer (ISO13485, 510(k), Regulatory)

Warwickshire

To £30k + benefits

This is a fantastic opportunity to join a fast growing, innovative, high technology medical devices company, developing an advanced system for use both in the home and in medical centres that will significantly improve the quality of life of the patients involved. The product is unique and set to make a significant impact on a multi-billion-dollar global market. The company now requires a Graduate / Junior Medical Devices Engineer with a minimum one year of experience of medical devices regulatory procedures for their role of Regulatory Engineer to provide technical support to the Regulatory and Risk Manager

Key Responsibilities
• To maintain the biocompatibility records for the materials and process being used in the manufacture a complex electro mechanical Medical Device.
• To undertake vigilance activities to support PMS requirements.
• To aid with regulatory compliance in markets to which company medical devices will be introduced.
• To provide support with the application for the FDA 510(k) process.
• To provide assistance in the application of market specific QMS requirements e.g. ISO 13485, FDA 21 CFR Part 820 etc.
• To ensure that all standards associated with company medical devices are maintained to the latest issue.
• To provide support to the risk process (BS EN ISO 14971) for TF maintenance and FDA submission.

Requirements/Qualifications

• A relevant degree (2:1 or higher), Masters or PhD involving a high level of research, data interpretation, and presentation preferably in Science or Engineering.
• Experience with the Medical Device Directive and the particular standards associated with Sterilisation and Biocompatibility of medical devices.
• An ability to use general office software (Microsoft Office) and other specialised software (e.g. online resource tools and databases).
• High level of curiosity and attention to detail, with a methodical way of working.
• Ability to communicate effectively, and credibly, with all colleagues and stakeholders (internal & external).
• Ability to analyse and understand data to enable decisions to be made objectively.
• Ability to follow instructions accurately and diligently.