What are the responsibilities and job description for the Senior Systems Engineer position at Katalyst Healthcares and Lifesciences?
Roles & Responsibilities:
Education and Experience:
- 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
- nticipate 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
Education and Experience:
- 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
- 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 and Jama requirements management tools preferred
- Knowledge of 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
- bility to work independently
- bility to manage simultaneously several projects and shift priority according to needs
- Demonstrated strong analytical and problem-solving skills
- bility 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
- bility to deliver results according to the plan