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.
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
- 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.