Product Development Engineer II
We are seeking a skilled Product Development Engineer II to join our team in Galway. As a technical leader, you will be responsible for leading product and process development activities from concept to commercialization.
The Role:
* Contribute to PDP projects, developing new concepts, prototypes, and products that meet customer requirements.
* Partner with Program Managers to generate project plans and execute them to schedule, ensuring customer requirements are met.
* Develop innovative concepts for new devices and processes that satisfy customer and regulatory requirements.
* Participate in brainstorming, troubleshooting, design reviews, and interdepartmental activities to advance projects from concept to commercialization.
* Maintain detailed documentation throughout all project phases.
* Work with other sites to support design and development activities, including customer meetings and visits.
Requirements:
* Degree in Mechanical Engineering, Biomedical Engineering, Polymer Engineering, or equivalent discipline.
* 3-5 years of work experience in Medical Device or similar industry.
* Demonstrated ability to develop Medical Devices from Concept to Commercialization.
* Experience in design and manufacture of Balloon Catheters and delivery systems.
* Familiarity with DFM/DFA principles, Phase-Gated PDP procedure, and medical device regulations (FDA, QSR, ISO 13485).
* Strong communication, presentation, problem-solving, and analytical skills.