Job title: Senior R&D Engineer
Location: Limerick
Benefits: Excellent salary, bonus, pension, healthcare + hybrid working

Company:
My client is a major European headquarters and manufacturing hub. Established in 1996, the facility develops and produces minimally invasive medical devices and features a dedicated Innovation Centre for clinician collaboration

Overview:

Lead Research & Development team in the design, development and taking to market of medical devices for the Cook Vascular division

Responsibilities:

• Design development, prototyping, test method design, design evaluation , design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely and effective manner.
• Product and project risk analysis and risk management.
• Develop prototypes which are consistent with the clinical and design requirements of the project.
• Research new therapies and design solutions to develop and complement the existing product portfolio.
• Introduce new equipment, materials and technologies.
• Lead technical development of projects.
• Lead all key design decisions to ensure quality design selection.
• Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved.
• Work closely to build effective relationships with cross functional groups to achieve project and company goals.
• Retrospective project reviews to understand lessons learned.
• Manage device evaluations.
• Compliance with Quality, Regulatory and company policies and systems.

• Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.
• Project lead for assigned Research & Development team/s including technical and project management leadership responsibly.

• Mentoring, coaching and development of direct reports if required.
• Foster innovation and creativity within team and perform disclosure reviews.
• Compliance with Quality, Regulatory and company policies and systems.

• Third level degree in Mechanical, Biomedical, Science, Design or similar discipline, Masters or Ph.D. level preferred but not essential.
• 5+ years’ experience is ideal.
• Proven Project Leadership abilities.
• Good Project Management methodology and skills.
• Proven track record in delivering quality results in a timely effective manner.
• Knowledge of anatomy and physiology.
• Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
• Innovative/Creative Engineer.
• Good manufacturing design and process understanding.
• Good working knowledge of Solidworks and/or Pro Engineer CAD.
• Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820).