Principal Systems Engineer
Role Overview
Vantive is a vital organ therapy company dedicated to extending lives and expanding possibilities. Our mission is to improve the dialysis experience through digital solutions and advanced services, and to transform vital organ therapies.
Responsibilities
Support the overall technical direction of Acute Therapies products.
Drive various portions of the product development cycle from feasibility through lifecycle management.
Develop design concepts/changes, product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.
Perform activities associated with the systems engineering of one or more products in various stages of the product lifecycle.
Understand clinical and user needs and apply them to product realization.
Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.
Propose and drive solutions to technical problems that are ambiguous and diverse in scope.
Resolve systems-related technical issues by applying problem-solving tools such as cause-and-effect diagrams, Pareto charts, etc.
Propose and drive solutions to technical problems that are ambiguous and diverse in scope.
Manage multiple projects and shift priorities as needed.
Teach and mentor others in life cycle management methodologies.
Qualifications
Bachelor’s degree and 5+ years or more of relevant experience, or Master’s degree and 4+ years or more of relevant experience, with a degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline.
Prior experience in medical devices, preferably for ICU or kidney care domains.
Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering.
Experience in medical devices, preferably for ICU or kidney care domains.
Track record in electro-mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military.
Prior experience with internet-connected, software-enabled devices and/or cyber security.
Working knowledge of system modeling language (SysML or UML) and requirement management tools.
Familiarity with statistical methods/tools for design and verification, e.g. DOE, sample size.
Excellent interpersonal, communication, and influencing skills.
Demonstrated strong analytical and problem-solving skills.
Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Applying / Overseeing (2)), Critical Systems (Applying / Overseeing (2)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Applying / Overseeing (2)), First Principles Thinking (Applying / Overseeing (2)), Instrumentation (Leading / Driving (4)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Manufacturing Process Knowledge (Leading / Driving (4)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Applying / Overseeing (2)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Product Knowledge (Leading / Driving (4)), Quality Management Systems (Leading / Driving (4)), Regulatory Compliance (Leading / Driving (4)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0)), Software Process Management (Leading / Driving (4)), Sterilization methods (Leading / Driving (4)), Systems Validation (Leading / Driving (4)).