Systems Engineer # 26-21712

US Tech Solutions; Plymouth (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

US Tech Solutions is seeking a Systems Engineer (contract) to guide the technical direction of Therapies products, from feasibility through lifecycle management, in support of ICU renal care devices.

You’ll drive requirements, design concepts, risk management, verification and validation, and cross‑functional collaboration under FDA/ISO/IEC design controls to deliver safe, compliant medical devices.

Qualifications

• Bachelor’s or Master’s in a relevant engineering/science field.
• 3+ years of experience in medical devices, ICU/kidney care preferred.
• Strong systems engineering knowledge across electro-mechanical and software.
• Experience with SysML/UML and requirement management tools.
• Familiar with Teamcenter, Jama, JIRA, and ALM.

Responsibilities

• Perform systems engineering across product lifecycle from development to post-market surveillance.
• Capture inputs from user needs, regulatory standards, human factors, quality, manufacturing, service, etc.
• Drive design concepts and requirements traceability.
• Maintain design history files and ensure risk and reliability alignment.
• Collaborate to meet FDA, ISO, IEC design controls and drive cross-functional solutions.

Skills

Systems engineering

Requirements management

SysML/UML

DOORS

Jama

JIRA

ALM

Verification & validation

Education

Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical, or related field

Tools

DOORS

Jama

Teamcenter

TrackWise8

JIRA

ALM

Job description

Duration: 12 Months Contract (Possible Extension)

Your Role

• 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

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.

By applying, you acknowledge that AI‑assisted tools may be used during hiring.