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
• Knowledge of DOORS Teamcenter TrackWise8 JIRA and ALM preferred
• 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

• Bachelors or Masters degree in Electrical Software Mechanical Biomedical or a related engineering or science discipline
• Three or more years of relevant experience

About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.