
Senior MES Engineer, Digital Solutions
- Cork
- Permanent
- Full-time
manufacture of new products adhering to procedures set out by Quality and
Regulatory Affairs.
- Independently research, design, develop, modify, and verify medical device systems
- Translate user needs to system requirements
- Modify existing system architectures or test designs
- Create new system architectures or test designs for simple product or features
- Allocate and decompose requirements on a multi-disciplinary (electrical, mechanical, software) project using modeling, simulation, budgeting, or mathematical techniques
- Lead Concept Phase activities for a feature
- Analyze and correct complex product design issues using independent judgment
- Lead analytical studies, including trade studies, sensitivity studies, optimization studies, performance assessments, and design assessments
- Lead system integration testing and verification activities
- Contribute to Product Risk Management activities
- Advance solutions by applying in-depth knowledge of customer needs, market, and competitive offerings
- Apply detailed knowledge of clinical procedures to author design inputs
- Support Voice of Customer sessions internally and with clinicians
- Demonstrate developing financial acumen
- Be proficient with and mentor others in usage of industry standards, including design requirements and test strategies per applicable regulations
- Lead creation and refinement of engineering documentation, such as the Design History file
- Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System
- Work cooperatively with all stakeholders to ensure project success
- Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology
- Support and execute segments of complex multifunctional teams to advance projects through the design /development/launch process
- Deliver high quality results with passion, energy, and drive to meet business priorities
- Collaborate with cross-functional teams to build partnership to achieve business objectives
- Bachelor's degree in Software Engineering/ Computer Science or related discipline & 4+ years of work experience
Technical Skills:
- Knowledgeable programming skills. Design new components applying various concepts design concepts and patterns
- Knowledgeable with integrated development environments (IDE) for projects
- Knowledgeable with tools for static/dynamic analysis, memory management, code coverage and techniques for analyzing software
- Knowledge in integration and deployment processes
- Software Development Life Cycle processes
- Knowledge in creating estimates for code implementation time/resource for assigned tasks and projects
- Knowledge from using Application Lifecycle Management /Traceability tools.
- Knowledge of regulatory and compliance standards applied to the SDLC (Software Development Life Cycle)