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 successful candidate will have a degree in Mechanical Engineering, Biomedical Engineering, Polymer Engineering or an equivalent discipline, with 3-5 years of work experience in Medical Device or similar industry. They will also have experience in design and manufacture of Balloon Catheters and delivery systems, as well as experience in Phase-Gated, PDP (Product Development Process) procedure.
Familiarity with medical device regulations FDA, QSR and ISO 13485 is essential. The ideal candidate will have strong communication and presentation skills, as well as strong problem solving and analytical skills.
Responsibilities:
* Lead product and process development activities from concept to commercialization.
* Develop new concepts, prototypes and products following the Corporate PDP procedure.
* Partner with Program Managers to generate project plans and execute them to schedule, within budget constraints.
* Develop innovative concepts for new devices and processes that satisfy customer and regulatory requirements.
* Maintain detailed documentation throughout all project phases.
Requirements:
* Degree in Mechanical Engineering, Biomedical Engineering, Polymer Engineering or equivalent discipline.
* 3-5 years work experience in Medical Device or similar industry.
* Experience in design and manufacture of Balloon Catheters and delivery systems.
* Experience in Phase-Gated, PDP (Product Development Process) procedure.
* Familiarity with DFM/DFA principles.
Estimated Salary: €80,000 - €110,000 per annum