Required Education/Experience:

• Bachelor's in Electrical, Software, Mechanical, Biomedical Engineering, or a related engineering/science discipline.

Required Qualifications:

• Prior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains.
• 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 cybersecurity.

Success in working with multi-functional, global teams.

• Excellent interpersonal, communication, and influencing skills.
• Ability to work independently.
• Ability to manage simultaneously several projects and shift priority according to needs.
• Demonstrated strong analytical and problem-solving skills.
• 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.
• Ability to deliver results according to the plan.

Required Technical Skills:

• Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering.
• Working knowledge of system modeling language (SysML or UML) and requirement management tools.
• Knowledge of DOORS and Jama requirements management tools .
• Knowledge of Teamcenter, TrackWise8, JIRA, and ALM preferred.
• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size.
• Knowledge of FDA, ISO and IEC design control procedures, regulations and standards.

Responsibilities:

• 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.
• 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.
• Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective.
• Craft design concepts and research methodologies that best meet current and future customer / business needs for a product or process domain area.
• Create and maintain design history file elements.
• 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.
• 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.
• Perform impact assessments on the requirements on an ongoing basis for any proposed design/material/process changes or observations from field/service/manufacturing. As needed, propose recommended mitigations with rationale.
• Influence stakeholders and cross-functional team members within the project.
• Drive adherence to FDA, ISO and IEC design control procedures, regulations and standards.
• Use various software tools and programs to complete the above responsibilities.
• Only those lawfully authorized to work in the designated country associated with the position will be considered.
• Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.

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