Senior Systems Engineer

• 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.

• 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.
• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size.
• 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., * Knowledge of DOORS, Teamcenter, TrackWise8, JIRA, and ALM preferred., * Accredited Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline.

• Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
• Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Pay: $62.50 per hour