Our client, a medical device company in Limerick looking for a highly talented Project Engineer to take responsibility for providing their medical design and project engineering knowledge for remediation compliance projects for their Medication Management Solution (MMS) business unit segment focusing on infusion pumps. The Project Engineer will need to demonstrate a good understanding of medical product development, risk analysis, device remediation, writing test protocols, verification and validation, and regulatory compliance.
To Be the Project Engineer:
- Demonstrate knowledge of advanced engineering technology, medical device development process, and medical product design and verification testing.
- Coordinating and influence medical remediation projects across multiple functions and other 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 MMS programs and projects.
- Clearly communicate information and ideas through a variety of media to people in manners 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 in the medical industry with a project engineering or medical design role.
- Ability to work in a team or individually with global collaboration.
- To be responsible for infusion device remediation projects and regulatory compliance.
- Knowledge of MDR/MDD/AIMD, global medical device/FDA regulations, ISO 14971, ISO13485, device remediation, UDI & device traceability, Sterilization, Material Biocompatibility, and Clinical Trials.
- Ability to maintain/update Design History Files (DHF) as well as write test protocols/procedures, plans, and reports.
- 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).
- Experience in DFSS (Design for Six Sigma) knowledge and experience is preferred.
- Experience with requirements traceability and requirements management tools (DOORS, etc.) and configuration tools (SAP, Agile PLM, etc.) is desirable.
- Strong technical writing skills, producing requirements specifications, risk reports, and test procedures
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