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Senior Systems Engineer

eTeam Inc.

Plymouth, MN

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JOB DETAILS
SALARY
$55–$57 Per Hour
SKILLS
Aerospace and Defense, Analysis Skills, Atlassian JIRA, Biomedicine, Communication Skills, Cross-Functional, Design Verification, Electricity, Electromechanical Engineering, Electromechanical Systems, FDA (Food and Drug Administration), File Maintenance, Human Factors, ISO (International Organization for Standardization), Intensive Care, International Electro-Technical Commission (IEC), Internet Security, Interpersonal Skills, Maintain Compliance, Manufacturing, Medical Equipment, Military, Modeling Languages, Multitasking, Needs Assessment, On Site Support, Problem Solving Skills, Product Design, Product Development, Product Lifecycle, Product Management, Project/Program Management, Regulations, Requirements Management, Risk, Risk Analysis, Risk Management, Software Engineering, Surveillance, System Integration (SI), Systems Engineering, Technical Support, Traceability, Unified Modeling Language (UML), United States Department of Energy (DOE), Validation Testing
LOCATION
Plymouth, MN
POSTED
30+ days ago
Job Title: Senior Systems Engineer
Location: Plymouth, MN
Duration: 12 Months

Description:
1 Summary
In the Systems Engineer role, you will be supporting the overall technical direction of Acute Therapies products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. Tasks may include product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.
2 What you'll be doing:
• 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
3 What you'll bring:
• 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, TeaCliententer, 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
4 Experience and/or Background:
• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
• Three or more years of relevant experience

About the Company

e

eTeam Inc.

Looking for a great job? Join eTeam. We’re looking for talented staffing professionals to join our staff. We also provide contract assignments and full-time jobs at Fortune 2000 Companies. We’ve been named one of the best companies to work for by Staffing Industry Analysts and New Jersey Business.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Other/Not Classified
FOUNDED
1998
WEBSITE
www.eteaminc.com

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