Joblink is pleased to be recruiting on behalf of a medical device validation business,
The Medical Device sector has never been under so much scrutiny with a lot of recent coverage in mainstream media with the implant files, bleeding edge documentary etc. The employer ensures that devices get to market safe without compromise.
This is a unique opportunity for someone who wants to learn about validation, risk management, technical documentation creation and other key documents to maintain device regulatory maintenance. You will learn about latest regulations including the MDR 2017/745 and IVDR 2017/746, you will become an expert in these fields by learning on the job.
This role would ideally suit a post graduate studying Bio/Medical Engineering or related subjects. The role will suit someone who wants to pursue a career in Medical Device development & manufacturing.
Specific activities will involve
1, Writing up technical specifications for a software programmer to develop an automated file creating software, so ability and experience of software is key.
2, Writing Gap Assessment documents against the MDD 93/42 EC and the MDR 2017/745 as well as the IVDD 98/79 EC and the IVDR 2017/746.
Key skills required:
Scientific or Engineering background, Medical Engineering or similar
Dependant on experience, as well as training on the job.
Remote working with occasional team meets at a location in Leeds.
Flexible around both student and business demands. Approx 6-18 hours per week
Testimonials from previous students –
"one of my best employment experiences. During my time there, I had the opportunity of gaining experience in validation and verification, risk management, design development and control plans, failure analysis and occurrence analysis. I also gained valuable insight into medical device regulation, regulatory bodies and relevant international standards. ...... fantastic mentor, providing support and encouragement, which made working part time and studying simultaneously more than manageable. .......ultimately helped me choose my career path!" – Gabriela Noe Ponce
“......a very rewarding experience. This unique opportunity gave me an insight into the medical device industry and helped me decide my career path. I became familiar with international standards, such as ISO 13485, while developing my skills in technical writing and risk management activities. Adnan is also great mentor who continuously encouraged me and gave me opportunities to attend events such as the Med Tech Innovation Expo in Coventry and the Medilink Pitching event. ......... has certainly been one of my best decisions!”