Senior Biomedical R&D Engineer with FDA background required by innovative medtech company in Galway to work on product design through the complete lifecycle.
REQUIREMENTS:
* Bachelor's Degree (BSc) in Biomedical, Mechanical, Polymer, Materials, or Industrial Engineering.
* A minimum of 5+ years of engineering experience in a MedTech company, with products and processes regulated by the FDA.
* Proven experience in the development and production of medical devices involving complex processes and assembly techniques, with a track record of delivering successful outcomes.
* High level of self-motivation and accountability, with a proactive attitude and a strong sense of ownership and responsibility for decisions, actions, and results.
* A team player who fosters a positive, supportive and goal-oriented culture, contributing to a respectful and productive work environment.
* High integrity with a commitment to leading by example for fellow employees.
* Excellent report writing and presentation skills.
DESIRABLE:
* A Masters or PhD in a related field is highly desirable, or an equivalent combination of education and technical experience.
RESPONSIBILITIES:
* Collaborate with the engineering team to advance the development of complex technologies, accelerating the next generation of devices to market.
* Foster an innovation mindset by identifying opportunities for improvement, conducting research, proposing solutions and submitting patent disclosures.
* Identify, evaluate and manage relationships with key technology and component suppliers, defining acceptance criteria and tolerances for materials, manufacturing processes and design.
* Plan and coordinate product development activities from concept through rapid prototyping, detailed design and design for manufacturing (DFM).
* Develop clinically relevant in-vitro and ex-vivo test protocols to evaluate device performance across a variety of clinical scenarios.
* Work closely with strategic marketing, clinical and commercial teams, as well as scientific advisors, to define patient and user needs, translating these into specific design input requirements.
* Creatively problem-solve as technical challenges arise, providing clear direction to the team while ensuring adherence to regulatory and quality requirements.
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