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Senior Systems Engineer

Epitec, Inc

Plymouth, MN

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JOB DETAILS
SALARY
$50–$55 Per Hour
LOCATION
Plymouth, MN
POSTED
7 days ago
Job Title: Systems Engineer
Contract Duration: 1 year, possible extension
Location: Plymouth, MN
Work Arrangement: Onsite
Pay Range: $50-$55/hour

Summary
In the Systems Engineer role, 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.

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
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, 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
Experience and/or Background
  • Bachelors or Masters degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
  • Three or more years of relevant experience

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About the Company

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Epitec, Inc

Epitec is a leading staffing and recruiting services company with a mission to make staffing personal. We go beyond traditional hiring by truly understanding our candidates and matching them with the perfect opportunities. We offer competitive compensation, career growth, and support throughout the entire process. Working with top Fortune 500 companies, we are recognized for our excellence with numerous awards, including Best & Brightest and diversity recognitions. At Epitec, we're redefining the future of employment. 

COMPANY SIZE
2,500 to 4,999 employees
INDUSTRY
Staffing/Employment Agencies
EMPLOYEE BENEFITS
Professional Development, 401K, Employee Referral Program, Life Insurance
FOUNDED
1978
WEBSITE
https://epitec.com/