Systems Engineer

Stefanini Group is hiring!

Stefanini is looking for Systems Engineer in Plymouth, MN

For quick Apply, please reach out to Sahnaj Pervin- call: 2489360650 / email: sahnaj.pervin@stefanini.com

Work Hours: M-F (40 hours)

Work Location: Plymouth, MN (Onsite) 

Shift: 1^st Shift.
 

In the Systems Engineer role, you will be supporting 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, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.

Responsibilities: :

• 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.

• 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.
• 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, 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.
    

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

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