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.

Qualifications

· 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.

Additional Information

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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