Systems Project Engineer (Medical Devices)
Job Description Summary
Our client is looking for a highly talented Systems / Project Engineer to take responsibility for providing their systems development and project engineering knowledge for remediation compliance projects over a 12-month fix-term contract on the RCI Systems Development Team.
Our clients purpose is to advance the world of health. As part of the team, you will be on the forefront of creating and developing specialized devices, software solutions and systems to help others.
The client is looking for a highly talented Systems / Project Engineer to take responsibility for providing their systems development and project engineering knowledge to medical device design and remediation compliance projects for their Medication Management Solution (MMS) business unit segment. The Systems / Project Engineer will need to demonstrate a good understanding of product development, requirements management, traceability, risk analysis, verification and validation, and device compliance. The suitable candidate has a background in either systems engineer or the medical industry with V&V and regulatory experience.
Be the Systems / Project Engineer:
• Demonstrate knowledge of advanced engineering technology, systems development process, and product design and verification testing.
• Coordinating and influence requirements traceability and medical remediation projects across multiple functions.
• Serve as a key resource to examine systems behaviour issues and bring resolution for existing products.
• Provide technical support to a wide range of systems-level problems pertaining to specific MMS programs and projects.
• Clearly communicate information and ideas through a variety of media to people 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.
• 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’ experience with requirements management (preferably in the medical industry).
• Ability to work in a team or individually with global collaboration.
• Experience with Requirements Management tools (DOORS, etc.) and configuration tools (TFS, etc.) is preferred (advantage with knowledge of DXL scripting).
• Ability to maintain/update Design History Files (DHF) as well as write test protocols/procedures, plans, and reports.
• 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, and Clinical Trials is desirable.
• 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