Job Opportunity
A seasoned medical device design professional is sought to join an Irish company in Cork. This exciting opportunity involves developing novel medical devices for the global market.
Key Responsibilities:
* Translate customer and patient feedback into actionable user needs.
* Design and prototype medical devices using CAD software and 3D printing.
* Contribute to design reviews, offering insights to optimize product performance and manufacturability.
* Support manufacturing with tooling, product design, and process validation.
* Analyse data sets using statistical techniques and generate reports.
* Perform on-site laboratory testing and manage off-site testing labs.
* 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.
Requirements:
* Bachelor of Science in Engineering or related field.
* 5+ years' experience in medical device development, particularly with FDA/EU regulated products.
* Experience with design verification and validation, medical device regulations (MDR and FDA), and ISO 14971.
* Generating technical files and regulatory documentation associated with medical devices.