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Machine Design Engineer

Machine Design Engineer

JVT AdvisorsProvidence , Rhode Island
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Job Summary :

This role will implement industrial automation for implantable cell encapsulation devices. The successful candidate will join the Automation Engineering Team and work on automation development, commissioning, optimization, process scale-up, and technology transfer of novel products and processes into Manufacturing. This role will focus on machine design.

Responsibilities :

  • Co-development of industrial automation used for production and assembly of cell encapsulation devices.
  • Manage the evaluation and selection of new equipment / technologies or modifications to existing systems to consider new processing technologies.
  • Support optimization and improvement in equipment / systems / processes
  • Assembled product machinery design; design for manufacturability; design for assembly; kinematic design & analysis; dynamic analysis; mechanisms; cam-follower or servo systems; stress analysis.
  • Establishes equipment documentation, including parts lists, mechanical drawings, and assembly drawings.

Requirements :

  • BS or MS in engineering or another relevant discipline.
  • 8+ years of experience (5+ years with Masters) working within a cGxP automation development environment (medical device preferred). Experience with device-biologic combination products is highly desirable.
  • Experience working with a variety of automation hardware, including but not limited to, custom-fabricated mechanical components, EPSON robotics, Universal Robotics, PC-based systems, Siemens PLC and related control system components, automated process instrumentation.
  • Experience validating manufacturing equipment and processes is required. Knowledge and experience in utilizing risk-based approaches to validation process development and validation are highly advantageous.
  • Ability to coach and train less experienced engineers.
  • Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21CFR820 is a plus. Knowledge of global cGMP requirements governing device or combination products.
  • Experience with 3D CAD software, preferably with Solidworks, is preferred.
  • Familiarity programming and troubleshooting industrial automation (Siemens PLC / HMI, Epson, Universal Robotics, PC-based systems, process instrumentation).
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    Design Engineer • Providence , Rhode Island