Senior Systems Engineer

Stefanini Group is hiring!

Stefanini is looking for Senior Systems Engineer in Plymouth MN (Hybrid)

For quick Apply please reach out to Sharad Chauhan call:/ email:

Work Hours:MF (40 hours)

Work Location:Plymouth MN (Hybrid)

Shift:1st Shift

You will be responsible for supporting the overall technical direction and work for novel 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. You will review and approve design concepts/changes and provide general direction to technical staff including ensuring that quality is built into the design during new product development and/or sustaining activities. Proactively supervising the program and developing strategies to mitigate technical risks is expected as well as reporting on the progress to senior management during routine cadence meetings.

• Perform the activities associated with the Systems Engineering of one or more products in different stages of the product lifecycle from new product development to postmarket surveillance.
• Understand clinical and user needs and apply them to product realization.
• Capture inputs for Requirements from various sources such as Standards User needs Regulatory Quality Human factors Manufacturing Service etc.
• Use knowledge of technology process and/or therapy domains to drive solutions and product design realization from a Systems perspective.
• Initiate develop and lead feasibility by crafting design concepts and research methodologies that best meet both current and future customer / business needs for a product or process domain area.
• Build and maintain Design History File elements and ensure traceability to requirements.
• Facilitate an improved understanding of the interrelationship between Requirements Risk and Reliability.
• Anticipate technical challenges and risk scenarios and then prepare lead and execute mitigation strategies to ensure safe and effective results.
• Resolve systemsrelated technical issues by applying problemsolving 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 change or an observation in the field/service or manufacturing to determine the impact and need for any mitigations then propose recommended mitigations with the rationale.
• Influence partners and multifunctional team members within the project.
• Drive consistency to FDA ISO and IEC design control procedures regulations and standards.
• Use various software tools and programs (e.g. DOORS) to complete the above responsibilities.
• Teach and mentor others in life cycle management methodologies.

• 3 years of industry work experience.
• Must possess sound knowledge of systems engineering and related areas such as electromechanical and software engineering.
• A demonstrated track record in electromechanical system development preferably medical devices or other highly regulated products such as military hardware.
• Demonstrated strong analytical and problemsolving skills.
• Success in working with multifunctional global teams.
• Excellent interpersonal/communication/influencing skills.
  
  

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 facetoface 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