Stefanini

Details:

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: 1st 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.

Pay Range:

$ 50.00 - $ 55.00