Manufacturing Engineer / Engineering Change Coordinator

  • Sep 17, 2021
  • /
  • Full time
The Manufacturing Engineer / Engineering Change Coordinator will have the opportunity to learn complex diagnostic instrumentation in a top medical device manufacturing company by providing support to the staff in engineering change-order initiation, management and implementation; as well as being deeply engaged in the creation and maintenance of product structures, master data, and manufacturing documentation, while ensuring shop-floor control, quality-system compliance, and ERP data integrity.

He/she will also work with other functional groups, such as Quality, Regulatory, Affairs, R&D, Service, Procurement, Production Planning, Master Data, and Document Control, and other associates that provide support to new product development or that sustain engineering projects.

Responsibilities:

  • Initiate, plan, and write engineering change orders to product design, product documentation, Bills of Materials, manufacturing/test/packaging procedures, process routings, tooling, compliance (EMC, safety, laser safety, ROHS, UDI, etc.), suppliers, and other items in a tightly controlled manufacturing environment.
  • Prepare, create, and maintain various types of SAP data objects
  • Redline bills of materials, assembly, test, and specifications documents.
  • Update other technical and compliance documents.
  • Coordinate the process of change review and impact analysis, ensuring that cross-functional requirements are identified and understood by the team.
  • Work in close communication with associates throughout the lifecycle of the projects, reviewing, updating, and submitting information for the preparation of documents and engineering change deliverables.
  • Ensure the accuracy of the information contained within controlled documents.
  • Follow proper document formats, material and description nomenclature, and correct SAP data types according to the standards of the company.
  • Communicate and collaborate with change reviewers, contributors, signatories, and Document Control Specialists.
  • Track and update the status of change orders.
  • Participate in manufacturing floor readiness during the implementation of changes, including material changeovers, material disposition (quarantine, scrap or rework), tool installation, Kanban setup and staff training.
  • Communicate changes to external suppliers to assist in the timely implementation at their sites.
  • Ensure that all the ECO changes happen in a timely manner, performing the required follow-up to prevent any delay or conflict with the business goals.
  • Keep up to date with the basic requirements for regulatory compliance in the work area and comply with these requirements.
  • Participate in training on regulatory issues affecting the area of work.
  • Communicate the regulatory compliance questions and issues to management in a timely way.
  • Generate and review manufacturing specifications, procedures, and other technical documents for medical device products.

Requirements

  • B. S. Degree in Manufacturing Engineering, Electrical Engineering, IT Engineering or related discipline.
  • +3 years of experience in product documentation and manufacturing operations.
  • Excellent written and verbal communication skills to author Engineering Change orders with change descriptions, justifications, and supporting information.
  • Must have good interpersonal skills and the ability to work in a team environment.
  • Proven track-record in the development of manufacturing assembly, test procedures, and product structures.
  • Proficient in the use of Microsoft Office (Excel, Word, Visio, PowerPoint, Project) and Adobe projects.
  • Ability to understand engineering drawings, Bills of Materials, and operational procedures.
  • Skills to assess and solve several high-visibility problems in a timely fashion.
  • Familiarity with ISO 9001 and 13485 standards.

Nice to have skills:

  • Experience providing support to complex medical devices.
  • Proficient with Pro-E, AutoCAD, and/or SolidWorks.
  • Working knowledge of SAP product documentation system and lifecycle management (engineering changes).
  • Experience leading meetings, presenting to large and diverse audiences.


Benefits

We offer amazing benefits or all our workers and try to make the process as easy as possible for any candidate with interest in working in this amazing company.

  • Remote work
  • Telework costs support towards Electricity and Internet
  • Permanent - Full Time Job
  • Work from Mon through Fri. WE LEAVE EARLY ON FRIDAYS!
  • Upper MX Law Benefits including Medical Insurance with Dental Discounts.
  • 100% Payroll scheme
  • Career Path
  • Cool offices and a collaborative environment.
  • American Company culture
  • Health & Wellness program for employees


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