Bachelor's or Master's degree in Electrical, Software, Mechanical, Biomedical, or related field with 3+ years of relevant experience.
Experience in medical devices, preferably in ICU or kidney care.
Knowledgeable in systems engineering, including electro-mechanical and software engineering.
Experience developing electro-mechanical systems in regulated industries like medical devices, aerospace, or automotive.
Familiarity with internet-connected devices and cybersecurity practices.
Proficient in system modeling languages (SysML/UML) and requirements management tools.
Responsibilities
Support the technical direction of Acute Therapies products throughout the product lifecycle.
Translate clinical and user needs into actionable product requirements.
Gather requirement inputs from various stakeholders and regulatory standards.
Develop and execute product design solutions using your technical expertise.
Craft research methodologies that adhere to customer and business needs.
Maintain design history file elements and ensure compliance with design control procedures.
Identify technical risks and lead mitigation strategies.
Benefits
Collaborative work environment focused on innovation in patient care technology.
Opportunity to impact critical healthcare solutions directly.
Engagement with cross-functional global teams.
Potential for professional development and career advancement.
Emphasis on work-life balance with standard working hours.
Full Job Description
Details:
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:
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.
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.
Job Requirements
Details:
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.
