Principal Systems Engineer: Risk Management - Transfusion and Transplant at Werfen

This person will be a key problem solver and a potential core team leader to plan and lead cross-funtional product development projects from concept to manufacturing.

• Use expert technical skills, conceive, plan and lead R&D product development activities to achieve project goals.
• Leverage understanding of advanced engineering principles, advanced engineering methods, data and judgment to influence the course of product development activities.
• Apply technical expertise in mechanisms, fluidics and electronics to lead efforts in test method development, implementation and validation for medical device/systems.
• Lead efforts in creating and developing fixtures and building test stations for characterization, experimenting and testing novel medical device/systems.
• Responsible for assessing design feasibility and testing product functionality and/or confirm product capabilities.
• Design experiments using DOE methodology and analyze the test results using statistical tools. Interpret the results correctly and provide feedback effectively for design improvements.
• Participate in the design of new products and design improvements to existing products.
• Participate in the evaluation and assessment of competitive products, processes and/or new trends.
• Engage with the OEM’s to provide technical oversight and guidance on the evolution of the design.
• Develop system modules to facilitate decisions concerning
  • System architecture
  • System requirements
  • Design tolerance allocation
  • Risk management
• Mentor system engineers

Education

• BS in Engineering required.  Advanced degree (MS/PhD) strongly preferred

Experience

• 8 years minimum relevant experience in product development/engineering (Minimum 5 years of medical device experience)
• Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
• Strong analytical and problem solving skills, as well as a good background in product development process
• Instrument automation or scientific instrumentation required 
• Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes
• Strong project management, prioritizing and multi-tasking skills to work within tight deadlines
• Design for Six Sigma (DFSS) experience highly desired
• Experience with requirements development from user needs
• Experience with system modelling and simulation
• Experience with design transfer functions
• Risk management expertise