Key Responsibilities:
* Own and manage systems engineering inputs and outputs for teams supporting either new product development or released products.
* Develop and maintain system/product design architecture and system/product requirements.
* Document system/product-level requirements and manage changes through team review, approval, and release processes.
* Lead the definition and documentation of system interfaces and interface requirements.
* Ensure design traceability from user needs through requirements to test evidence and support the use of appropriate software tools for creating and maintaining trace matrices.
* Lead system/product-level integration, bug/defect tracking, and configuration management.
* Conduct system evaluations through the development and execution of system-level test plans and protocols, including data analysis, interpretation, and communication of results in written reports, design reviews, and interactive discussions.
* May lead system verification and validation activities for a multi-functional project team, including protocol writing, execution, and reporting.
* Contribute to the transition from research and development to manufacturing/service and support resolving system issues for products in the field.
* Liaise between research and development and quality/reliability functions to inform/support functions based on quality procedures, including risk analysis, verification/validation for specific subsystems.
* Critically assess designs and test plans through robust technical/design reviews.
* Facilitate broad perspectives, knowledge, and experiences to promote understanding and resolution of in-market and product development issues.
* Provide technical solutions to a wide range of complex problems. Exercise latitude in determining technical objectives and selecting techniques and evaluation criteria for obtaining resolution using risk-based assessment (including failure mode and effects analysis and input into system hazard analysis).
Required Skills and Qualifications:
* Extensive background in electro/mechanical medical device product development, in vitro diagnostic 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.
* Ability to lead complex experiments independently, perform statistical analysis, interpret experimental results, and make sound conclusions.
* Apply creative problem-solving skills to novel or complex applications.
* Ability to self-direct and manage own work while possessing strong interpersonal skills with the ability to collaborate in multi-disciplinary team settings, influence decision making, and build group consensus.
* Perform in a 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 the 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.
About This Opportunity:
This company is a global leader in medical technology, advancing the world of health by improving medical discovery, diagnostics, and the delivery of care.
The Limerick site is a global hub for innovation within this company's Life Sciences segment. It focuses on the development of next-generation diagnostic instruments, connected-health solutions, and smart medical technologies that help detect infections, improve patient outcomes, and support clinical decision-making.
Since opening in 2017, the centre has grown rapidly and now hosts a multidisciplinary team of scientists, engineers, software developers, and clinical experts. The facility plays a critical role in advancing this company's portfolio through hardware and software innovation, systems engineering, cybersecurity, and biocompatibility research.