Product Development Engineer II is required by CareerWise Recruitment for our Galway based client. You will participate as a team member in the Product Development process from concept to commercialization of novel Medical Devices. As Product Development Engineer, you will act as a technical leader for projects and may be assigned engineers, technicians, interns, or operators to supervise and/or provide guidance. You will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.
THE ROLE:
* Contributor on PDP projects leading product and process development activities from concept to commercialization.
* Develop new concepts, prototypes, and products from concept to commercialization following the Corporate PDP procedure meeting or exceeding customer requirements.
* Partner with Program Managers to generate project plans and execute the project plan to schedule, within budget constraints, meeting customer requirements.
* Develop innovative concepts for new devices and processes that satisfy customer and regulatory requirements.
* Participate in brainstorming and troubleshooting activities.
* Participate in design reviews to support advancement of projects from concept to commercialization following the PDP procedure.
* Participate in design for manufacture/design for assembly activities.
* Participate in the organization and execution of interdepartmental activities to ensure advancement of projects from concept to commercialization following Company procedures.
* Maintain detailed documentation throughout all project phases.
* Participate in design and process verification and validation activities working with manufacturing and quality personnel.
* Work with other sites to support design and development activities.
* Participate in customer meetings and visits.
* Familiar with medical device regulations FDA, QSR, and ISO 13485.
REQUIREMENTS:
* 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.
* Experience in design and manufacture of Balloon Catheters and delivery systems.
* Experience in Phase-Gated, PDP (Product Development Process) procedure.
* Familiar with DFM/DFA principles.
* Strong communication and presentation skills.
* Strong problem-solving and analytical skills.
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