Senior Systems Engineer

Select Source International; Plymouth (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

Select Source International in Plymouth, MN seeks a Senior Systems Engineer for a 12-month contract to advance PrisMax ICU therapies. You will drive feasibility through lifecycle management, shaping design concepts, requirements, DHF, risk management, and system integration.

Applicants should have a Bachelor's or Master's in engineering and 3+ years in medical devices, with SysML/UML, DOORS/Jama, and cross-functional collaboration skills to ensure regulatory compliance and robust product

Qualifications

• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or related engineering field with 3+ years in medical devices.
• Experience in ICU or kidney care domains is preferred.
• Knowledge of SysML/UML and requirements management tools.
• Familiarity with design control processes per FDA/ISO guidelines.

Responsibilities

• Lead systems engineering across product lifecycle from feasibility to post-market surveillance.
• Translate clinical needs into product requirements and design concepts.
• Maintain DHF elements and ensure traceability of requirements and risks.
• Collaborate with cross-functional teams to mitigate technical risks and meet regulatory standards.
• Perform impact assessments on design changes and drive mitigation strategies.

Skills

Systems engineering

SysML/UML

Requirements management

DOORS

Jama

JIRA

Teamcenter

Traceability

Cross-functional collaboration

Analytical problem solving

Education

Bachelor's or Master's in Electrical/Software/Mechanical/Biomedical engineering

Tools

DOORS

Jama

Teamcenter

TrackWise8

JIRA

ALM

Job description

Your Role

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.

Job Title: Senior Systems Engineer

Duration: 12 months contract.

Location: Plymouth, MN 55441

Your Role

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.

Vantive 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