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Senior Manufacturing Engineer

Job Description

JOB SUMMARY

The Senior Engineer, Manufacturing, under minimum supervision of the Engineering Manager, shall create or modify technical documentation, such as component specification, drawing, traveler, manufacturing and test procedures for electrical, electronic, mechanical components and sub-assemblies. Additionally, develop assembly and test fixtures with appropriate documentation to aid in production of a surgical robot; conduct root cause investigations of non-conforming materials, provide troubleshooting assistance, rework, and disposition instructions. Finally, provide leadership during PFMEA, Verification & Validation (V&V) activities, including protocol development and implementation. The Sr. 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.

DUTIES & RESPONSIBILITIES

  • Perform assembly, testing, and troubleshooting of electro-mechanical assemblies.
  • Prepare Bill of Material, New Part Request & CO for production release, and support document control in CO 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, as required.
  • 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

Qualifications

QUALIFICATIONS

Required Qualifications

  • 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 2015+ 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. 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.

Preferred Qualifications

  • Strong knowledge of PLM tools (ARENA, ePDM, Epicor).

COMPETENCIES

  • Drives quality results
  • Optimizes work processes
  • Provides high quality decisions
  • Demonstrates Initiative
  • Strong time management skills
  • Directs work of technicians

PHYSICAL DEMANDS & WORK ENVIRONMENT

  • Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
  • Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
  • Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
  • Occasionally work around moving mechanical parts.
  • Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
  • Must be able to travel as business necessitates (up to 5 % Travel%).

Disclaimer:

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management s right to assign or reassign duties and responsibilities to this job at any time.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Senior Manufacturing Engineer

Thinksurgical
Fremont, CA
Full Time

Published on 01/13/2022

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