Katalyst Healthcares and Lifesciences
Katalyst Healthcares and Lifesciences

Senior Systems Engineer

Plymouth, MN, US • Posted 30+ days ago • Updated 13 days ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Product Development
  • Surveillance
  • Human Factors And Ergonomics
  • Product Design
  • Research
  • SAP BASIS
  • Field Service
  • Manufacturing
  • Cross-functional Team
  • ISO 9000
  • Design Controls
  • Electrical Engineering
  • Biomedicine
  • Science
  • Systems Engineering
  • Software Engineering
  • Mechanical Engineering
  • Medical Devices
  • Aerospace
  • Military
  • Internet
  • Cyber Security
  • Systems Modeling
  • SysML
  • UML
  • IBM Rational DOORS
  • Jama
  • Requirements Management
  • Teamcenter
  • Trackwise
  • JIRA
  • Application Lifecycle Management
  • Design Of Experiments
  • Communication
  • Management
  • Analytical Skill
  • Problem Solving
  • Conflict Resolution
  • Collaboration

Summary

Roles & 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
  • 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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 9d322712aa6f15bf070eefa57288359f
  • Posted 30+ days ago
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