Project Engineer

Employment Type

: Full-Time

Industry

: Engineering



Responsibilities


Own

  • Lead the systems engineering approach for a development product
  • Develop test plans for our products and coordinate external testing agencies
  • Manage risk management documentation in accordance with ISO 14791
  • Manage design input requirements and traceability to design outputs


Support

  • Contribute to the development of a Technical File for CE Marking and FDA regulatory submissions
  • Procure prototypes, services, and software as needed to support product development
  • Contribute to R&D and design of new product features
  • Design and execute experiments as needed to evaluate the feasibility of new product features and improvements
  • Work with the manufacturing team on new systems, fixtures, software, and develop tools to improve the efficiency and quality of production activities
  • Perform root cause analysis to investigate product failures and defects


Learn

  • Learn Common Sensing’s technology and the unique applications for it in improving the experience for people who use injectable medicine
  • Opportunities to learn about systems engineering, risk management,  and project management


Teach

  • Demonstrate strong verbal and written communication skills
  • Clearly communicate results, conclusions, and recommendations  to team members


Education, Experience, Skills, and Background Requirements

  • 1-10 years of experience working in product development and engineering,
  • Bachelor’s degree or higher in Biomedical Engineering, Mechanical Engineering, Electrical Engineering or a related field
  • Ability to work with and manage small teams
  • Familiarity with the product development life-cycle, GMP requirements and risk analysis techniques


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