Senior Software Engineer

The Carrera Agency; Minneapolis, Saint Paul (MN, MN); On-site; USD 123,984,000 - 151,536,000; Full time

Job summary

The Carrera Agency is seeking a Systems Engineer to support acute therapy medical products in a 1-year contract. You will lead feasibility through lifecycle management, including design concept, requirements management, DHF maintenance, and risk management for ICU CRRT devices. This role emphasizes cross-functional collaboration and regulatory compliance.

Join a team advancing connected medical systems with attention to patient safety and device reliability in high-stakes environments.

Qualifications

• Bachelor's or Master's in Electrical, Software, Mechanical, Biomedical or related field.
• 3+ years of relevant experience in medical devices or regulated industries.
• Experience in electro-mechanical system development and design controls.
• Familiarity with FDA/ISO/IEC design control practices.

Responsibilities

• Perform systems engineering across products from development to post-market.
• Capture requirements from user needs, regulatory and quality inputs.
• Develop DHF elements and maintain design history files.
• Drive risk management, system integration and verification/validation activities.
• Ensure compliance with design control procedures and standards.

Skills

Systems engineering

Medical devices

Requirements management

Regulatory compliance

Risk management

System integration

Verification & validation

Education

Bachelors/Masters in engineering

Tools

DOORS

Jama

SysML/UML

JIRA

ALM

Teamcenter

TrackWise8

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 Contract (W2)

* Location: Plymouth, MN (onsite)

* Compensation: Starting at $45 per hour (W2) plus benefits

Seeking a Systems Engineer to support the overall technical direction of acute therapy medical products. You will drive various aspects of the product development cycle—from feasibility through lifecycle management—including design concept development, requirements management, traceability, design history file (DHF) structure and maintenance, product risk management, system integration, and verification and validation of medical devices.

The products you'll support are used in intensive care units (ICUs) to deliver continuous renal replacement therapy (CRRT) for patients experiencing acute kidney injury. The organization is building new platforms, devices, and connected systems aimed at making therapy administration more efficient, consistent, and intuitive for clinical care teams.

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