Our systems are used in the intensive care unit (ICU) to support patients experiencing life-threatening acute kidney injury. Clinicians rely on our devices to deliver continuous renal replacement therapy, helping to maintain critical kidney function while patients recover. We’re building new platforms, devices, and connected systems to make therapy administration more efficient, consistent, and intuitive—so care teams can focus on the patient.
It is seeking a System Engineer (contract) to support the overall technical direction of 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 development of design concepts/changes, 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:
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
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 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
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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Numbers & Facts
Location
Plymouth, MN
Skills
Aerospace and Defenseunmatched
Atlassian JIRAunmatched
Biomedicineunmatched
Cross-Functionalunmatched
Design Verificationunmatched
Electricityunmatched
Electromechanical Engineeringunmatched
Electromechanical Systemsunmatched
FDA (Food and Drug Administration)unmatched
File Maintenanceunmatched
Human Factorsunmatched
ISO (International Organization for Standardization)unmatched
Intensive Careunmatched
International Electro-Technical Commission (IEC)unmatched
Internet Securityunmatched
Kidney Diseaseunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Medical Equipmentunmatched
Militaryunmatched
Modeling Languagesunmatched
Needs Assessmentunmatched
On Site Supportunmatched
Problem Solving Skillsunmatched
Product Designunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Product Managementunmatched
Regulationsunmatched
Renal Replacement Therapyunmatched
Requirements Managementunmatched
Riskunmatched
Risk Managementunmatched
Software Engineeringunmatched
Surveillanceunmatched
System Integration (SI)unmatched
Systems Engineeringunmatched
Teamcenterunmatched
Technical Supportunmatched
Traceabilityunmatched
Unified Modeling Language (UML)unmatched
United States Department of Energy (DOE)unmatched
Validation Testingunmatched
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