About the Role:
We are seeking an experienced Systems Engineer to join our team in Limerick. As a key member of our multidisciplinary team, you will play a critical role in leading systems engineering efforts for both new product development and released products.
The successful candidate will be responsible for developing and maintaining system and product design architectures, ensuring system-level requirements are properly documented and managed, and leading the definition of system interfaces.
You will ensure traceability from user needs to test evidence, supports configuration management, and drive integration and defect tracking efforts. Additionally, you will oversee system evaluation processes, including test planning, execution, and data analysis, while facilitating collaboration between R&D, Quality, and Reliability teams to resolve technical challenges.
Responsibilities:
* Ownership of Systems Engineering inputs and outputs for teams supporting either NPD or released product
* Development and maintenance of system/product design architecture and system/product requirements
* Documentation of system/product-level requirements and managing changes via team review, approval, and release process
* Definition and documentation of system interfaces and interface requirements
* Design traceability from user needs through requirements to test evidence and supports use of appropriate software tools for creation and maintenance of trace matrices
* System/product-level integration, bug/defect tracking and configuration management
* System evaluation process through development and execution of system level test plans and protocols including data analysis, interpretation and communication of results and their impact through written reports, design reviews, and interactive discussions
* May lead system verification and validation activities for multi-functional project team including protocol writing, execution and reporting
* Contribution to transition from R&D to manufacturing/service and support resolving system issues for products in field
* Liaison between R&D and Quality/Reliability functions to inform/support functions based on quality procedures including risk analysis, verification/validation for specific subsystems
* Critical assessment of designs and test plans through robust Technical and/or Design Reviews
* Facilitation of broad perspectives, knowledge and experiences to promote understanding and resolution of in-market and product development issues
* Technical solutions to wide range of difficult problems Exercise latitude in determining technical objectives of assignment methods and in selecting techniques and evaluation criteria for obtaining resolution using risk-based assessment (including dFMEA analysis and input into System Hazard Analysis)
Requirements:
* Extensive background in electro/mechanical medical device product development, IVD device development, or lab automation development
* Strong technical background and experience within Systems Engineering – Requirements Management, Hazards Analysis, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Reliability Engineering, and Failure Modes Effects Analysis
* Lead complex experiments independently, perform statistical analysis, interpret experimental results, and make sound conclusions
* Apply creative problem-solving skills to novel or complex applications
* Able to self-direct and manage own work while possessing strong interpersonal skills with ability to collaborate in multi-disciplinary team settings, influence decision making, and build group consensus
* Perform in fast-paced, agile environment
* Collaborative leader committed to success of overall project; capable of encouraging others and leading without authority
* Proven technical expertise and leadership in medium to large sized projects, with ability to meet technical objectives and solve sophisticated challenges under conditions of ambiguity and rapid change
* Strong problem-solving and debugging skills and an interest in learning new technologies
Benefits:
This is a fantastic opportunity to join a global leader in medical technology and advance your career as a Systems Engineer. You will have the chance to work on cutting-edge projects, develop your skills and expertise, and contribute to the company's mission to improve patient outcomes and deliver innovative medical solutions.