Our client is looking for a highly talented Senior R&D Engineer to take responsibility for providing their medical design and R&D knowledge to further development efforts on the Research and Development Engineering Team for for the Medication Management Solution (MMS) business unit segment, with specific focus on infusion (volumetric and syringe) pump systems and device remediation. The Senior R&D Engineer will need to demonstrate a good understanding of fundamental R&D medical design engineering principles, procedures and techniques across the spectrum to connect various functional elements related to the development and through life of electronic hardware and software systems.
The Senior R&D Engineer will need to demonstrate a good understanding of fundamental R&D medical design engineering principles, procedures and techniques across the spectrum to connect various functional elements related to the development and through life of electronic hardware and software systems and subsystems. The suitable candidate has a background in the medical industry with design engineering and regulatory compliance, product remediation, technical risk analysis, traceability, and documentation approval. The suitable candidate should also be able to analyse customer/user needs to produce detailed requirements specifications and systems architecture for the creation of new or enhancement of existing hardware and software products that may affect multiple systems.
The suitable candidate has a background in the medical industry with design engineering and regulatory compliance experience, as well as a proven background with product remediation, clinical testing, technical risk analysis, traceability, and documentation approval following a formal Quality Management System. The suitable candidate should also be able to analyse user needs to produce detailed requirements specifications and test protocols for new and existing infusion system hardware and software products. Also, the suitable candidate should be effective at collaborating and coordinating technical medical device issues across several global sites and multiple business functions (marketing, operations, PMO, quality, medical affairs, etc.).
Be the Senior R&D Engineer:
- Demonstrate knowledge of advanced system-level medical device technology and R&D development process through V&V and clinical trials.
- Demonstrate detailed knowledge of medical product design process.
- Coordinating and influence product development across multiple disciplines and BD global locations.
- Serve as a key resource to examine product behavior issues and bring to resolution for existing infusion products.
- Provide technical support to a wide range of engineering problems pertaining to specific MMS infusion programs and projects.
- Clearly communicate verbal and written information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
- Assures deep technical understanding of infusion products.
- Able to drive technical excellence and design decisions throughout the global organization.
- Identify technical risks early and often; establishes mitigation options, and tracks resolution.
- Making stakeholders and their needs a primary focus of one’s actions; developing and sustaining productive business relationships on a global front.
- Setting high goals for personal and group accomplishment; pushing oneself and others to exceed performance goals and standards; strong and independent drive for success.
- Establishing courses of action and plans for self and others to ensure that work is completed efficiently; successfully encourages others to take responsibility for their work packages.
- Degree qualified (or equivalent) ideally in biomedical, mechatronics, mechanical, electrical, electronics, software or systems engineering.
- Demonstrable track record in professional work experience with 10+ years’ overall experience in the medical industry.
- Ability to work in a team or individually with global collaboration.
- Ability to support Regulatory Affairs with engineering input for design related submissions & resubmissions (510K/Notifications).
- To be responsible for the completion of risk benefit analysis documentation including documenting background of devices types, use case, harms, treatments, benefits, competitor devices, clinical studies, biocompatibility & materials and literature review.
- Maintain technical risk management files for existing devices (i.e. dFMEA, Risk Benefit Analysis) and take input from Clinical Evidence Reports (CER).
- Knowledge of MDR/MDD/AIMD, global medical device/FDA regulations, ISO 14971, ISO 13485, EN/IEC 60601, device remediation, UDI & device traceability, Sterilization, Material Biocompatibility, and Clinical Trials is preferred.
- Experience working within formal medical QMS processes and system tools (i.e., SAP, Agile PLM, etc.) is preferred.
- Experience in DFSS (Design for Six Sigma) knowledge and experience is preferred.
- Experience with formal Requirements Management and document configuration tools is an advantage, and;
- Strong technical writing skills, producing requirements specifications, risk reports, and test procedures.
For further information on this Senior Medical R&D Engineer role in Limerick please contact Bimi Felix on 086 8395533 / email@example.com
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