Medical Device Design Professional
A challenging opportunity has arisen for an experienced Medical Device Design Professional to join our client’s professional core team in Cork, Ireland.
The successful candidate will be responsible for translating customer and patient feedback into user needs, developing novel medical device concepts, and contributing to design reviews to optimise product performance and manufacturability.
Main Responsibilities:
* Translate voice of customer and voice of patient information into user needs.
* Develop concepts (CAD) and prototypes (3D print) of novel medical devices.
* Contribute to design reviews, offering insights and suggestions to optimise product performance and manufacturability.
* Analyse data sets using statistical techniques and generate reports to summarise the information.
* Execute design controls activities per FDA 21 CFR Part 820.
* Generate design verification/validation protocols and reports.
* Conduct risk management activities per ISO 14971.
* Create quality system and regulatory documentation, such as user requirements specifications, design inputs and outputs.
Required Skills & Qualifications:
* Bachelor of Science in Engineering, Mechanical Engineering/Biomedical.
* 5+ years’ experience working for a medical device company whose products and processes are FDA/EU regulated.
* Experience in design and development of medical devices per ISO 13485 & FDA 21 CFR Part 820.
* Knowledge of medical device regulations (MDR and FDA) and experience with ISO 14971 and IEC 62366 is an advantage.