Senior System Engineer

CARERRA AGENCY; Plymouth (MN); On-site; USD 90,000 - 98,000; Full time

Job summary

CARERRA AGENCY is seeking a System Engineer for electro‑mechanical system development in medical devices. You will contribute to lifecycle management of advanced ICU devices, with cross‑functional collaboration and exposure to connected medical systems.

This is a 1‑year W2 contract starting September 2026 in Plymouth, MN, offering competitive compensation and benefits. Responsibilities include systems engineering across product lifecycle, requirements capture, risk and reliability analysis, and

Qualifications

• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or related engineering
• 3+ years of relevant experience
• Prior experience in medical devices, preferably in ICU or kidney care domains
• Demonstrated track record in electro‑mechanical system development, preferably in regulated industries

Responsibilities

• Perform systems engineering activities across one or more products at various stages of the product lifecycle, from development to post‑market surveillance
• Understand clinical and user needs and apply them to product realization
• Capture requirements inputs from diverse sources including user needs, regulatory standards, human factors, quality, manufacturing, and service
• Apply knowledge of technology, process, and therapy domains to drive system level design realization
• Develop design concepts and research methodologies addressing current and future customer needs
• Create and maintain design history file elements and risk management artifacts
• Influence stakeholders and cross‑functional team members throughout the project
• Drive adherence to FDA, ISO, and IEC design control procedures and standards
• Utilize software tools and programs to fulfill responsibilities

Job description

System Engineer, Electro-mechanical system development, experience with Medical Devices

Reference #

Job-11888

Job Description

If you’re a systems engineer with a passion for medical technology and a desire to make a meaningful impact in critical care, this is an exceptional opportunity. You’ll contribute to the development and lifecycle management of advanced devices used in ICU to support patients with life‑threatening kidney conditions—work that genuinely matters. With a collaborative, cross‑functional team environment, exposure to cutting‑edge connected medical systems, and a clear scope of meaningful engineering work, this contract role offers both professional challenge and purpose.

• Start Date: September 2026
• Duration: 1 Year W2 Contract
• Location: Plyomouth, MN
• Compensation: Starting at $45 per hour (W2) plus benefits

What You’ll Be Doing

• Perform systems engineering activities across one or more products at 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 requirements inputs from diverse sources including user needs, regulatory standards, human factors, quality, manufacturing, and service
• Apply knowledge of technology, process, and therapy domains to drive solutions and product design realization from a systems perspective
• Develop design concepts and research methodologies that address current and future customer and business needs
• Create and maintain design history file elements
• Facilitate an improved understanding of the interrelationships between requirements, risk, and reliability
• Anticipate technical challenges and risk scenarios, and prepare, lead, and execute mitigation strategies
• Resolve systems‑related technical issues using problem‑solving tools such as cause‑and‑effect diagrams and Pareto charts
• Propose and drive solutions to technical problems that are ambiguous and broad in scope
• Perform impact assessments on requirements for proposed design, material, or process changes, or observations from field, service, or manufacturing; recommend mitigations with supporting rationale as needed
• Influence stakeholders and cross‑functional team members throughout the project
• Drive adherence to FDA, ISO, and IEC design control procedures, regulations, and standards
• Utilize various software tools and programs to fulfill the responsibilities of the role

Education & Experience

• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
• 3 or more years of relevant experience
• Prior experience in medical devices, preferably in the ICU or kidney care domains
• A demonstrated track record in electro‑mechanical system development, preferably in medical devices or other regulated industries such as aerospace, automotive, or military

Technical Skills

• Sound knowledge of systems engineering and related areas including electro‑mechanical and software engineering
• Prior experience with internet‑connected, software‑enabled devices and/or cybersecurity
• Working knowledge of system modeling languages (SysML or UML) and requirements management tools
• Knowledge of DOORS and Jama requirements management tools preferred
• Familiarity with Teamcenter, TrackWise8, JIRA, and ALM preferred
• Familiarity with statistical methods and tools for design and verification, such as DOE and sample size calculations

Qualities

• Proven success working with multi‑functional, global teams
• Excellent interpersonal, communication, and influencing skills
• Ability to work independently and manage multiple projects simultaneously, shifting priorities as needed
• Strong analytical and problem‑solving skills
• Ability to develop solutions and make recommendations in collaboration with project leaders
• Creative approach to identifying technical risks early and developing effective mitigations
• Consistent track record of delivering results according to plan