23 month FTC role in Carrigtwohill, Cork
Who we want:
Senior MES Engineer on the Digital Solutions team to be responsible for setting up best in class manufacturing processes to enable the different value streams in the Patient Specific End to End project.
What you will do:
You will innovate and develop the various project elements with an emphasis on the manufacturing process, technology and procedures required for the
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
Business Responsibilities:
• 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
Med Device Compliance:
• 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
General Responsibilities:
• 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
Minimum Qualifications:
• Bachelor's degree in Software Engineering/ Computer Science or related discipline & 4+ years of work experience
Preferred Qualifications:
Technical Skills:
• Knowledgeable programming skills. Design new components applying various concepts design concepts and patterns
Design and Development Skills:
• 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 Process Skills:
• 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)