Senior Systems Engineer
Limerick - 103535
Our client, a medical device company in Limerick are currently looking to recruit a Senior Systems Engineer for their site.
As a Senior Systems Engineer you will responsibility for providing their systems knowledge to further development efforts for their Medication Management Solution (MMS) business unit segment focusing initially on infusion pumps. The Senior Systems 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 and should 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.
- 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 & global locations.
- Serve as a key resource to examine systems behavior issues and bring resolution for existing infusion products.
- Provide technical support to a wide range or systems-level problems pertaining to specific MMS 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 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