At {company}, we are seeking an experienced Product Development Engineer to join our team in Galway. This role offers a unique opportunity to work with a renowned medical device R&D company that specializes in developing and manufacturing braided catheters and medical tubing.
About the Company
{company} is a leading player in the medical device industry, known for its innovative products and collaborative work environment. Our recent expansion has led to a surge in global R&D programs transferring to our Galway site, creating numerous career development opportunities for talented engineers like you.
The Opportunity
You will play a crucial role in the product development process, from concept to commercialization, working on innovative medical devices that improve patient outcomes. As a Product Development Engineer, you will serve as a technical leader on projects, guiding engineers, technicians, interns, or operators, and contributing to design reviews to support project advancement.
Salary & Benefits
We offer a competitive salary up to €60,000 DOE plus benefits, including health insurance, pension, bonus, flexible working hours and days.
Job Responsibilities
1. Contribute to projects by leading product and process development activities from concept to commercialization.
2. Develop new concepts, prototypes, and products, ensuring they meet or exceed customer requirements by following established Product Development Processes (PDP).
3. Collaborate with Program Managers to create and execute project plans that adhere to schedule, budget constraints, and customer requirements.
4. Generate innovative concepts for new devices and processes that comply with customer and regulatory requirements.
5. Engage in brainstorming and troubleshooting sessions.
6. Participate in design reviews to support project advancement from concept to commercialization.
7. Contribute to design for manufacturing and assembly activities.
8. Coordinate and execute interdepartmental activities to ensure project progression according to established procedures.
9. Maintain detailed documentation throughout all phases of the project.
10. Participate in design and process verification and validation activities in collaboration with manufacturing and quality teams.
11. Work with other sites to support design and development activities.
12. Engage in customer meetings and visits as needed.
13. Stay informed about medical device regulations, including FDA, QSR, and ISO 13485.
Job Requirements
* Degree in mechanical engineering, biomedical engineering, polymer engineering, or a related field.
* 3-5 years of experience in the medical device industry or a similar field.
* Proven ability to develop medical devices from concept to commercialization.
* Experience in the design and manufacture of balloon catheters and delivery systems.
* Familiarity with phase-gated Product Development Process (PDP) procedures.
* Knowledge of Design for Manufacturing (DFM) and Design for Assembly (DFA) principles.
* Strong communication and presentation skills.
* Excellent problem-solving and analytical abilities.