Senior Systems Engineer

Stefanini, Inc; Plymouth, Northern (MN, KY); Hybrid; USD 69,000 - 73,000; Full time

Job summary

Stefanini Group is seeking a Senior Systems Engineer in Plymouth, MN to support Acute Therapies products. The role focuses on applying systems engineering across the product lifecycle, from feasibility through lifecycle management, ensuring design controls and regulatory compliance.

The position involves collaboration with cross-functional teams, understanding clinical needs, and developing design concepts, requirements, and verification strategies to deliver safe, effective medical devices.

Qualifications

• Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical, or related field.
• Prior experience with medical devices or regulated products is preferred.
• Knowledge of systems engineering, electro-mechanical and software engineering.

Responsibilities

• Perform systems engineering activities for one or more products through the lifecycle from development to post-market surveillance.
• Understand clinical and user needs and translate them into product realization.
• Capture requirements from various sources and manage design history files.
• Drive risk management, system integration, verification and validation for medical devices.
• Influence stakeholders and ensure adherence to design control regulations and standards.

Skills

SysML/UML

Analytical thinking

Strong communication

Independent work

Education

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

Tools

JIRA

ALM

DOORS

Jama

Teamcenter

TrackWise8

Job description

Job Details

Job Title: Senior Systems Engineer

Location: 1405 Xenium Ln N, Suite 150, Plymouth MN 55441

Posted: 8/28/2026

Job ID # 64771

Job Category: Systems Engineering

Position Type: Contract

Duration: Long Term

Shift: 1

Remaining Positions: 1

Stefanini Group is hiring!

Stefanini is looking for a Senior Systems Engineer in Plymouth MN 55441

Job Title: Senior Systems Engineer

Location: 1405 Xenium Ln N, Suite 150, Plymouth MN 55441

Timings: 7:00 AM to 3:30 PM; 30 minutes break

Responsibilities

• Our PrisMax 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 (CRRT), 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.
• Client is seeking a System Engineer (contract) to 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 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
• Success in working with multi-functional, global teams.
• Excellent interpersonal, communication, and influencing skills.
• Ability to work independently.
• Ability to manage simultaneously several projects and shift priority 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 up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks.
• Ability to deliver results according to the plan.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face to face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.

Pay Range: $ 50.00 - $ 53.00