Senior R&D Engineer – Limerick
A strong Medical Device multinational is seeking an experienced R&D Engineer to join their growing team. The ideal candidate will showcase proven experience in the medical device industry.
- Demonstrate knowledge of advanced system-level technology and R&D development process.
- Demonstrate knowledge of medical product design.
- Coordinating and influence product development across multiple disciplines.
- Serve as a key resource to examine systems behavior issues and bring resolution for existing infusion products.
- Provide technical support to a wide range of systems-level problems.
- Making customers/stakeholders and their needs a primary focus of actions.
- Developing and sustaining productive business relationships.
- Setting high goals for personal and group accomplishment.
- Establishing courses of action and plans to ensure that work is completed efficiently.
- Consistently apply systems engineering techniques.
- BSc. ideally in biomedical, mechatronics, mechanical, electrical, electronics, software or systems engineering.
- 10+ years experience in the medical industry.
- Ability to work with global collaboration.
- Ability to support Regulatory Affairs with engineering input for design.
- Ability to completion of risk benefit analysis documentation.
- Ability to maintain technical risk management files for existing devices.
- Knowledge of MDR/MDD/AIMD, global medical device/FDA regulations, ISO 14971, ISO13485, device remediation, UDI & device traceability, Sterilization, Material Biocompatibility, Clinical Trials, Agile PLM advantageous.
- Experience in DFSS (Design for Six Sigma) knowledge.
- Experience with formal Requirements Management tools and configuration tools advantageous.
- Knowledge of model-based systems engineering (MBSE), design methods using SysML or UML, and modelling tools advantageous.
- Understanding agile development methodologies and scrum practices advantageous.
Strong technical writing skills, producing requirements specifications, risk reports, and test procedures.
- Experience in traditional systems engineering development, architectural design and project engineering.
- Must be authorised to work in Ireland.
Please contact Emer Moore to discuss in confidence