Job Description
A Design Engineer is required to join our Cork based client – an award winning Irish medical device company, developing novel medical devices for the global market. Excellent opportunity to join a professional core team with exposure across engineering & commercial functions.
Role of this position
* Research and translate voice of customer and voice of patient information into a series of user needs.
* Develop concepts (CAD) and prototypes (3D print) of novel medical devices.
* Contribute to design reviews, offering valuable insights and suggestions to optimise product performance and manufacturability.
* Provide support for manufacturing of new products with tooling, product design and process validation.
* Analyse data sets using appropriate statistical techniques and generating reports to summarise the information.
* Responsible for on-site laboratory testing
* Manage off-site testing labs and test houses required for external testing
* Execute design controls activities (design verification, design validation and design transfer) per FDA 21 CFR Part 820.
* Generate design verification/validation protocols and reports.
* Conduct risk management activities per ISO 14971.
* Responsible for creation of quality system and regulatory documentation, such as user requirements specifications, design inputs and outputs.
JOB REQUIREMENTS
* Bachelor of Science in Engineering, Mechanical Engineering/Biomedical and 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, especially design verification and validation.
* Knowledge of medical device regulations (MDR and FDA) and experience with ISO 14971 and IEC 62366 is an advantage.
* Experience in generating technical files and regulatory documentation associated with medical devices, such as risk analysis, dFMEA, DIOVV and related documents.