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Senior Systems Engineer

Plymouth, MN, US • Posted 5 days ago • Updated 4 hours 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

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 5 days ago

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