Systems Engineering S

Systems Engineer
In the Systems Engineer role, you will support the overall technical direction of Acute Therapies products. Tasks may include product requirements management, traceability, design history file (DHF) structure and maintenance, product risk management, system integration, verification, and validation of medical devices.

Perform 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.

Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, and service.

Craft design concepts and research methodologies that best meet current and future customer and business needs for a product or process domain area.

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.

Perform impact assessments on the requirements on an ongoing basis for any proposed design, material, or process changes or observations from field, service, and manufacturing.

Influence stakeholders and cross‑functional team members within the project.

Use various software tools and programs to complete the above responsibilities.

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 cybersecurity.

Working knowledge of system modeling language (SysML or UML) and requirement management tools.

Ability to manage several projects simultaneously and shift priorities according to needs.

Ability to solve problems, develop solutions, and make recommendations in collaboration with project leaders.

Creative problem solver - identify technical risks upfront, develop and execute mitigations, and provide team direction on how to remove or avoid roadblocks.

Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline.

The work environment is a mix between office and lab settings.

This is a Contract position based out of Minneapolis, MN.

If eligible, the benefits available for this temporary role may include:

Medical, dental & vision

401(k) Retirement Plan - Pre‑tax and Roth post‑tax contributions available

Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Short and long‑term disability

Health Spending Account (HSA)

Employee Assistance Program

Application Deadline
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

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