Systems Engineer

Pyramid, Inc

Plymouth, MN

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JOB DETAILS

SALARY

$55–$57 Per Hour

JOB TYPE

Contractor

SKILLS

Aerospace and Defense, Analysis Skills, Artificial Intelligence (AI), Atlassian JIRA, Biomedicine, Communication Skills, Consulting, Cross-Functional, Design Verification, Electricity, Electromechanical Engineering, Electromechanical Systems, Employee Benefits, FDA (Food and Drug Administration), File Maintenance, Human Factors, ISO (International Organization for Standardization), Information Technology & Information Systems, 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, Short Messaging Service (SMS), Software Engineering, Surveillance, System Integration (SI), Systems Engineering, Teamcenter, Technical Support, Traceability, Unified Modeling Language (UML), United States Department of Energy (DOE), Validation Testing

LOCATION

Plymouth, MN

POSTED

30+ days ago

Immediate need for a talented Systems Engineer. This is a 06+months contract opportunity with long-term potential and is located in Plymouth, MN(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 26-09366 Pay Range: $55/hr - $57/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: 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. 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. Key Requirements and Technology Experience: Key skills; Prior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains. Knowledge of systems engineering and related areas such as electro-mechanical and software engineering. Prior experience with internet-connected, software-enabled devices and/or cyber security. Knowledge of DOORS, Teamcenter, TrackWise8, JIRA, and ALM preferred. Working knowledge of system modeling language (SysML or UML) and requirement management tools. 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. 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. Our client is a leading IT Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. 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About the Company

Pyramid, Inc

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