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Implements and optimizes technological concepts concerning systems and / or solutions.

Senior Systems Engineer

Position Overview

As Senior Systems Engineer, Critical Care, you will report to the Head of Systems Development and Integration and will be responsible for leading systems design and development from product definition through transfer to manufacturing for critical care medical devices.

A Senior Systems Engineer will utilize Systems Engineering principles and best practices to drive systems integration efforts for development of reliable high-performing next generation systems as well as for continuous improvement of on-market Critical Care products.

Responsibilities

As Senior Systems Engineer, Critical Care, your primary focus would be on blood gas devices, and you will be responsible for:

Being the Subject Matter Expert (SME) on systems engineering and work closely with the core team technical lead to enable the successful execution of systems engineering activities, incorporating inputs from cross-functional team members.Leading and driving robust development efforts ensuring the technical adequacy of design outputs from hardware, software, and consumables engineers to demonstrate that systems performance and reliability goals align with user needs and systems design input requirements.Critically analyzing complex systems problems and identify potential interactions utilizing structured problem-solving approaches / methods and propose solution options to optimize overall system performance.Driving the evaluation and selection of proposed hardware, software solutions, facilitate tradeoffs, and developing study approaches collaborating with required functional disciplines (e.g. sensor development, manufacturing, quality, marketing, PMO).Effectively communicating to clearly convey technical concepts to both technical and non-technical stakeholders.Developing system level requirements and further decomposing into lower-level subsystem requirements in a holistic manner capturing hardware and software interdependencies and interfaces.Creating high-quality documentation including technical reports, design review records, verification plans, protocols and reports.

Required Knowledge/Skills, Education, and Experience

Minimum a bachelor’s degree in systems engineering, mechanical, electrical or a technically equivalent field. Advanced degrees preferred.Minimum 10 years’ experience in a product / systems development environment with a lead technical role and track record of delivering product / systems solutions.Experienced with influencing, guiding subject matter experts and key stakeholders to navigate successfully through project challenges while maintaining focus on DFX principles (X = Manufacturability, Testability, Reliability etc.) for the systems under design.Knowledge and hands-on experience with utilizing one or more of the common tools used in product design and development of electro-mechanical systems (e.g., SolidWorks for mechanical design and analysis).Experienced with utilizing systems engineering fundamentals to drive definition of system / product features working with cross-functional project teams.Requires broad experience in systems design and development involving integration of hardware and software platforms involving fluidics, optics, sensors and consumables.Demonstrated systems engineering leadership and interpersonal skills with experience in directing technical teams.

Preferred Knowledge/Skills, Education, and Experience

Experience with point of care blood gas diagnostic medical device development.Working knowledge of FDA, ISO, IVDD or IVDR regulations for medical devices.

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