#5734 - Manufacturing Engineer

Are you interested in working with the World’s leading AI-powered Quality Engineering Company? Read on!

Qualitest is looking for a Manufacturing Engineer in San Francisco, CA, United States to join our rapidly expanding teams!

Required skills:

Perform assembly, testing, and troubleshooting of electro-mechanical assemblies.

Prepare Bill of Material, New Part Request & ECO for production release, and support document control in ECO implementation.

Develop and update manufacturing process instructions and fixtures for new and existing designs.

Develop and update test procedures and fixtures for electro-mechanical components and assemblies, including the final product.

Responsible for activities related to development or update of a PFMEA, including collaboration with production personnel, as required.

Provide leadership in protocol writing, setup and execution of the V&V activities.

Represent Engineering in the Material Review Board meetings and assist with the disposition and root cause investigation of non-conforming materials.

Participate in CAPA resolution and closure.

Record and analyze test results, and prepare accurate, grammatically correct, and complete reports.

Create or Modify 3D models & drawings using GD&T ANSI Y14.5.

Create wiring diagrams, simple artworks, and labels.

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 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 2013 for three-dimensional modeling and two-dimensional drawing.

Experience using Enterprise Resource Planning system (Epicor is preferred).

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.

Can identify components and read schematics. Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. Attendance and Punctuality are essential function of the position.

Job Responsibilities:

• Analyze System requirements to determine testability, completeness and consistency
• Work closely with development & system engineering team to better understand requirements for effective testing
• Communicate with team members to understand the software and how it will be used
• Design and develop test cases and procedures to evaluate the system requirements
• Perform test execution on the target device and capture the results.
• Document software defects, using a bug tracking system, and report defects to software developers on time
• Work closely with multi-functional teams to understand requirements and use-cases.
• Monitor bug resolution efforts.

3 must haves:

Minimum of 5 years experience

V&V activities

electronics or mechanical engineering background

experience in medical devices with QSR/FDA ISO 13485:2003 or in a highly regulated manufacturing environment.

Experience using Solidworks 2013 for three-dimensional modeling and two-dimensional drawing.

Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards