Overview:

The Mechanical Automation Engineer will be primarily responsible for the design, validation, and implementation of automation, fixtures, and processes needed for the production manufacture of point-of-care, in-vitro diagnostic instruments and disposable test cassettes. The position requires a minimum of 3 years of relevant experience, proficiency in Solid Works 3D Design, a strong foundation in the integration of automation, and experience working under FDA QSR/ISO 13485 environments.

Duties:

• Development and optimization of production processes.
• Facility planning and material flow.
• Implementation and integration of automation systems.
• Production scale-up from manual, to semi-automated and fully automated solutions
• Fixture design.
• IQ, OQ, PQ
• Design verification and validation per ISO 13485.

• All development activities will meet or exceed ISO 13485 design control and risk assessment requirements.

   

  Skills:
  

• At least 3 years of experience in the development and/or manufacture of IVD/Medical devices
• Experience with programmable logic controllers
• Experience with machine vision systems
• Experience in the integration of automated production systems.
• Experience in ultrasonic welding.
• Experience working with lyophilized reagents is desirable.
• IQ, OQ, PQ
• Proficient with Solid Works 3D design.
• Prior experience working under FDA QSR / ISO 13485 regulated environment.
• Experience with 6 sigma, lean manufacturing, and 5S a plus.
  

Education:

• A minimum of a BS in Mechanical Engineering, Industrial Technology, or other relevant Engineering discipline.