Job Description Summary
BD’s purpose is to advance the world of health. As part of our team, you will be on the forefront of creating and developing specialized devices, software solutions and systems to help others. Our Urology Critical Care group is looking for a highly talented Senior Systems Engineer to apply their advanced technical expertise to the help launch new products for patient care.
Be the Senior Systems Engineer:
- Has a strong background in either electromechanical IVD, lab automation or medical device design and development.
- Has experience in preparing or working to a 510k premarket submission for the FDA.
- Can translate multiple inputs from Regulatory, Quality, Marketing, Product Security etc., into product requirements, specifications and detailed trace matrices.
- Critically assess and challenge design proposals and prototypes through robust design reviews and comprehensive testing protocols and clear results.
- Can critically assess the design and test implications for product requirements and specifications.
- Assures deep technical understanding and evaluation of technical issues and timely delivery of solutions.
- Concisely communicates technical challenges and possible solutions and manage key decisions and tradeoffs.
- Responsible for coordination of system-level product development, architecture, integration and test.
- Provide expertise in identifying key system behavior issues and driving the implementation of their solutions for new and existing products.
- Establishing courses of action and plans for self and others to ensure that work is completed efficiently; successfully encourages others to take responsibility for their work packages.
- Making customers/stakeholders and their needs a primary focus of one’s actions; developing and sustaining productive business relationships on a global front.
- Bachelor of Engineering or Science Degree with a strong technical background within Systems Engineering, medical device development, or similar roles.
- A minimum of 5-10 years related work experience.
- Ability to work in a team, or individually, with global collaboration and interacting with external development partners.
- Excellent communication skills across departments, e.g. cross-engineering (with Electrical, Mechanical, Software, Firmware etc.) cross-functional (with Marketing, Regulatory, Clinical Representatives, Quality etc.)
- Must have very strong writing skills.
- Attention to detail paramount.
- A post graduate degree and/or MBA is strongly desired.
- Experience in electromechanical device design and development.
- Experience in development to IEC 60601 and IEC 62304 standards desired.
- Experience in multiple areas within Systems Engineering such as; model-based system engineering, requirements development and management, system architectural planning and design, interface control, systems integration and characterisation testing.
- Experience interpreting experimental results, performing statistical analysis or DFSS (Design for Six Sigma) techniques and FMEA methods is preferred.
- Experience with Requirements Management tools (DOORS, etc.) and configuration tools (Azure, TFS, etc.) is a plus.
- Knowledge of model-based systems engineering (MBSE), design methods using SysML or UML, and modelling tools (Rhapsody, Enterprise Architect, etc.) is a plus.
You will have the ability to critically think, solve problems (i.e. solution seeker) and meet deadlines. You will have a conscientious, detail-orientated approach to work
If you’re a team player who is passionate about manufacturing and ‘advancing the world of health’ and we’ve just described your career aspirations, then please APPLY.
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Primary Work Location
IRL Limerick - Castletroy