They are currently searching for a Senior Systems Engineer to join the Global Device Engineering team located in their Dublin site in a permanent role.

The Position:

A Senior Systems Engineer to join the Global Device Engineering team located in their Dublin site in a permanent role.

• Understands the intent, constraints and value proposition of a given project. Aligns system engineering activities to meet these.
• Acquires expertise in existing device performance and behavior to guide lifecycle management projects.
• Conceptualizes complete solutions. Creates or coordinates the design solutions for novel or complex problems
• Creates and assesses system architecture options with cross-functional (electrical / mechanical / SW) team to define optimal system solution.
• Works with program core team members including Software, Electrical and Mechanical engineering along with Quality and Regulatory to ensure conformance to established design development processes and procedures
• Translates User Needs (from multiple internal and external stakeholders) into verifiable technical design requirements.
• Decompose system requirements to subsystem requirements (including SW), ensuring functional coverage.
• Executes work under design controls process and in compliance with the company's quality management system.
• Works with program managers to help create project schedules. Leads and facilitates architectural and design decisions to ensure on-time delivery of projects. Escalates technical issues in a timely fashion to Systems Engineering leadership.
• Works with multiple internal stakeholder groups (Verification, Validation, Quality, Commercial, Clinical, Regulatory Affairs etc.) to resolve system definition challenges.
• Assesses and clearly communicates technical status of projects

The Person:

• BS or MS degree in a scientific or engineering discipline
• 5+ years Systems Engineering experience in complex electro-mechanical products
• 3+ years medical device development experience
• Applied knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, IEC 60601, IEC 62304 etc.).
• Excellent written and verbal communications skills to interface with internal and external stakeholders.
• Strong leadership to make rapid/clear decisions based on multi-disciplinary team recommendations.
• Self-starting, motivated individual who takes ownership of their tasks
• Familiarity with requirements management tools (e.g., DOORS, Polarion, Jama), as well as modelling-based systems engineering tools (e.g., Enterprise Architect, IBM Rhapsody)

• Experience working with cross functional teams.

To learn more, apply online or contact Déanna Healy on +353 87 636 9263 or please submit an updated CV.