Principal Systems Engineer: Risk Management

5 days ago


Norcross, Georgia, United States Werfen North America Full time $100,000 - $150,000 per year

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.

Responsibilities

  • 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

Qualifications
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


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