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Managing product requirements and flow down.
Defining product requirements for the module / component teams.
Conducting component and product integration.
Driving CTQ / Risk trades within the teams designing features.
Integrating activities that span multiple components and products for maximum performance.
Managing interface between the different Engineering groups during development.
Driving validation and verification activities for the overall product, including system level testing.
Managing the overall product configuration and configuration control system.
Ability to apply UX concepts to the design of features. Understanding of Formative and Summative Testing.
Developing new solutions under guidance and/or in a team setting or based upon precedents in the organizations.
Leading analytical and design activities using proven technologies and vested approaches and methods.
Specifying needs, communicating about project approach, and presenting outcomes of research done.
Bachelor’s degree in an engineering or STEM discipline. From an accredited college/university.
Minimum 4 years of Systems Engineering experience or medical device development experience.
Ability to integrate and process information from different engineering disciplines.
Master's Degree.
Understanding of the Systems Development Process, Medical related standards and QMS process.
Familiarity with System Modeling Language (SysML) and MBSE.
Understanding of risk management practices.
Familiarity with testing methodologies.
Familiarity with UX design and testing concepts.
Experience on Systems activities in the development on products.
Knowledge on requirements management, including capture, decomposition, & tracing.
Effective cross functional communication skills.
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