Systems Development Engineer
Job Description Summary
Our client, a market leading medical device company is looking for a highly talented Senior Systems Engineer to take responsibility for providing their systems knowledge to the company for further development efforts for their Diabetes Care business unit segment focusing on infusion pumps. The Systems Development Engineer will need to demonstrate a good understanding of fundamental/traditional systems engineering principles, procedures and techniques across the spectrum to connect various functional elements related to the development and through life of electronic and software systems and subsystems. The suitable candidate has a background in the medical industry with design engineering and regulatory experience. 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.
Be the Systems Development Engineer:
• Demonstrate knowledge of advanced system-level technology and systems development process.
• Demonstrate knowledge of medical product design.
• Coordinating and influence product development across multiple disciplines and global locations.
• Serve as a key resource to examine systems behaviour issues and bring resolution for existing infusion products.
• Provide technical support to a wide range of systems-level problems pertaining to specific Diabetes Care programs and projects.
• Clearly communicate 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.
• Making customers/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.
• Consistently apply systems engineering techniques such as requirements synthesis, decomposition, use case modelling, traceability, risk management, verification and validation, product architecture, etc.
• Degree qualified (or equivalent) ideally in biomedical, mechatronics, mechanical, electrical, electronics, software or systems engineering.
• Demonstrable track record in professional work experience with 5+ years 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 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, ISO13485, device remediation, UDI & device traceability, Sterilization, Material Biocompatibility, Clinical Trials, Agile PLM is preferred.
• Experience in DFSS (Design for Six Sigma) knowledge and experience is preferred.
• Understanding agile development methodologies and scrum practices are desirable.
• Experience with Requirements Management tools (DOORS, etc.) and configuration tools (TFS, etc.) is a plus.
• Knowledge of model-based systems engineering (MBSE), design methods using SysML or UML, and modelling tools (Rhapsody, Enterprise Architect, etc.) is a plus.
• Strong technical writing skills, producing requirements specifications, risk reports, and test procedures, and;
• Experience in traditional systems engineering development, architectural design and/or project engineering.
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287