Product Development Engineer II
We are seeking a Product Development Engineer II to join our team in Galway.
The Role:
You will contribute to the development of novel Medical Devices, leading product and process development activities from concept to commercialization.
You will develop new concepts, prototypes, and products following the Corporate PDP procedure, meeting or exceeding customer requirements.
* Develop innovative concepts for new devices and processes that satisfy customer and regulatory requirements.
* Partner with Program Managers to generate project plans and execute the project plan to schedule, within constraints, meeting customer requirements.
You will participate in brainstorming and troubleshooting activities, design reviews, and interdepartmental activities to ensure advancement of projects.
Maintains detailed documentation throughout all project phases and participates in design and process verification and validation activities.
Familiar with medical device regulations (FDA, QSR, ISO 13485) and experience in Phase-Gated, PDP procedure, DFM/DFA principles, and strong communication and presentation skills.
Requirements:
* Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Polymer Engineering, or other equivalent discipline.
* 3-5 years work experience in Medical Device or similar industry IS A PREREQUISITE.
* Demonstrated ability to develop Medical Devices from Concept to Commercialization.
Please note that we operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo, and Dublin.