Systems Engineer

Job Title:

Systems Engineer Job Description In the Systems Engineer role, you will support the overall technical direction of Acute 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 product requirements management, traceability, design history file (DHF) structure and maintenance, product risk management, system integration, verification, and validation of medical devices. Responsibilities 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. 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, and service. Use knowledge of technology, process, and 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 and 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 and Pareto charts. 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, or process changes or observations from field, service, and manufacturing. 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. Essential Skills 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. Knowledge of DOORS, Teamcenter, TrackWise8, JIRA, and ALM preferred. Familiar with statistical methods/tools for design and verification, e.g., DOE, sample size. Success in working with multi-functional, global teams. Excellent interpersonal, communication, and influencing skills. Ability to work independently. Ability to manage several projects simultaneously and shift priorities according to needs. Demonstrated strong analytical and problem-solving skills. 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. Ability to deliver results according to the plan. Additional Skills & Qualifications Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline. Three or more years of relevant experience. Work Environment The work environment is a mix between office and lab settings. Job Type & Location This is a Contract position based out of Minneapolis, MN. Pay and Benefits The pay range for this position is $45.00 - $49.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 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)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Minneapolis,MN.

Application Deadline This position is anticipated to close on May 21, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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 actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use 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.