The Manufacturing Engineer, under minimum supervision of the Engineering Manager, shall create or modify specification, drawing, and procedure for electrical, electronic, mechanical components and sub-assemblies, and perform assemblying, testing, and root cause investigation of non-conforming materials. The Manufacturing Engineer is required to follow all their functions while maintaining compliance to Food & Drug Administration (FDA) Quality System (QSR’s) and international Organization of Standards (ISO) 13485:2003.
Travel Requirements:
This position may require limited travel (less than 5%) to support the company’s objectives.
Job Responsibilities:
· Create or Modify 3D models & drawings using GD&T ANSI Y14.5.
· Create wiring diagrams, simple artworks, and labels.
· Prepare Bill of Material, New Part Request & ECO for production release, and support document control in ECO implementation.
· Develops and updates manufacturing process instructions for new and existing designs.
· Disposition and root cause investigation of non-conforming materials.
· Develops and updates test procedures for electromechanical assemblies.
· Performs assembly, testing, and troubleshooting of electromechanical assemblies.
· Analyze and record test results, and prepare written testing documentation.
· Work with multiple tasks, under the timely requirement.
· Other duties or special projects as required in order to meet company’s objectives.
· Prefer four-year degree (Bachelor’s or technical certification) in electronics or mechanical engineering or an equivalent combination of education and experience in medical devices with QSR/FDA ISO 13485:2003 or in a highly regulated manufacturing environment.
· Need a minimum of two to five years of experience in manufacturing engineering of complex electromechanical devices. Experience with IEC60601-1 compliant devices preferred.
· Knowledge of electronic components such as resistors, capacitors and filters.
· Experience using Solidworks 2010-2013 for three dimensional modeling and two dimensional drawing.
· Experience using Enterprise Resource Planning system.
· Have the ability to define instructions that are moderately complex in nature.
· Must be able to read, understand, and update assembly prints, parts list, wiring diagrams and wiring lists. Have the ability to identify components and read schematics.
Think Surgical Inc,.offers a fast-paced work environment, very competitive compensation, medical and 401K retirement plan benefits.
We are an equal opportunity employer and encourage diversity.
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