R&D Engineer II - Galway Fantastic opportunity to join a thriving medical device company in Galway.
In this role as R&D engineeryou will work on design, development, and commercialization of next generation transcatheter heart valve systems.
Apply mechanical and biomedical engineering principles to the design and performance evaluation of prosthetic heart valves and delivery systems.
Job Purpose:Maintain products of moderate complexity.
Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish/verify performance standards for modified products, processes, and materials and creates/maintains design-related technical notes building a complete design history.
Key Responsibilities: Use of design change process to ensure proposed changes are systematically and thoroughly analyzed before beginning the change process.
Whenever product changes are proposed, justification is written or data is collected to verify that the design intent is still met.
Works cross-functionally with project management, quality, manufacturing, regulatory, clinical and marketing to ensure project success.
Work collaboratively with manufacturing to ensure alignment between print requirements and process validations.
Demonstrates design control knowledge through generation of high quality deliverables.
Maintains product performance through Quality Investigations and ensuring rigorous support for design changes.
Works independently to plan and schedule own activities necessary to meet timelines.
Designs and coordinates standard engineering tests and experiments, as required.
Performs troubleshooting on products/process problems as related to design, material or process.
Summarizes, analyzes and draws conclusions from test results.
Prepares standard reports/documentation to communicate results to technical community.
Responsible for engineering documentation.
May train and/or provide work direction to technicians and interns.
Must be able to provide technical guidance within a team and be an effective communicator within a multidisciplinary and international organisation.
Applies the Product Development Process (PDP) methodologies.
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Qualifications & Experience: Primary Degree in Biomedical or Engineering discipline.
Min.
FETAC level 8.
2 + years industry experience - medical device an advantage Proven ability to work within a regulated industry environment and with a track record of accomplishments.
Experience in a post-commercial R&D role is essential Experience with Design Control and Design Change is necessary.
Experience with post-commercial product support is an advantage.
Experience with PTA Balloons and/or Self-Expanding Stents is an advantage.
Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
Knowledge of EU MDR is an advantage.
Self-Starter with the ability to work independently to plan, schedule and execute activities necessary to meet project timelines to schedule.
Excellent interpersonal and communication skills with good leadership abilities.
Excellent analytical and problem-solving skills.
Get in touch to find out more on this excellent career opportunity.
Call: Email: Skills: R&D Delivery systems Design DMAIC LEAN Medical device hear valves
