Senior Systems Engineering

Client is seeking a System Engineer (contract) to support the overall technical direction of Acute Therapies products. Tasks may include development of design concepts/changes, product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.

Perform the activities associated with the systems engineering of one or more products in various stages of the product lifecycle from new product development to post-market surveillance

Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.

Craft design concepts and research methodologies that best meet current and future customer / business needs for a product or process domain area

Facilitate an improved understanding of the interrelationship between requirements, risk and reliability

Anticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal results

Perform impact assessments on the requirements on an ongoing basis for any proposed design / material / process changes or observations from field / service / manufacturing. Influence stakeholders and cross-functional team members within the project

Use various software tools and programs to complete the above responsibilities

Bachelor's degree or Master's degree and three 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 intensive care unit (ICU) or kidney care domains

Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering

A 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

Ability to manage simultaneously several projects and shift priority according to needs

Ability to solve problems, develop solutions, and make recommendations in collaboration with project leaders

Creative Problem Solver - identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks

This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status