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.
- 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.