BD (Becton, Dickinson and Company) Manufacturing Engineer 1 - Engineering Change Coordinator in San Jose, California
Job Description Summary
The Manufacturing Engineer I - Engineering Change Coordinator will be a key contributor within the Manufacturing Engineering team in managing engineering change orders, including facilitating the impact assessment and communication to affected functions, collecting and/or creating engineering deliverables, and participating in change implementation into Production and other customers, internal and external.
The Manufacturing Engineer I – Engineering Change Coordinator will have the opportunity to learn complex diagnostic instrumentation in a top medical device manufacturing company by supporting the Manufacturing Engineering staff in engineering change order initiation, management and implementation.
The ME I will be deeply engaged in creating and maintaining product structures, master data and manufacturing documentation, while ensuring shop-floor control, quality system compliance and ERP data integrity, and over-all Production readiness during essential product and process changes.
The ME I will work with other functional groups, such as Quality, Regulatory Affairs, Research & Development, Service, Procurement, Production Planning, Master Data and Document Control and other associates supporting new product development or sustaining engineering projects.
In the process, the ME I will earn a brilliant experience in his/her career by becoming familiar with complex flow cytometry instruments along with the operational and technical activities in manufacturing and sustaining these medical devices.
Duties and Responsibilities
Initiate, plan and author 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 controlled manufacturing environment.
Prepare, create, and maintain various types of SAP data objects. Redline bills of materials, assembly, test, and specification documents. Update other technical and compliance documents.
Coordinate with various functions for change review and impact analysis, ensuring cross-functional requirements are identified and understood for affected items, personnel and processes .
Work closely with multiple associates throughout the duration of projects, in reviewing, updating and submitting information for the preparation of various documents and engineering change deliverables.
Ensure accuracy of information within controlled documents.
Follow proper document formats, material and description nomenclature, and correct SAP data types per company standards.
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 implementation of changes, including material changeovers, material disposition (quarantine, scrap or rework), tool installation, Kanban setup, and personnel training.
Communicate changes to external suppliers to assist in timely implementation at their sites.
Ensure all ECO changes occur in a timely manner and perform the necessary follow-up to prevent any conflicts or delays to business goals.
Keep abreast of the basic requirements for regulatory compliance in own area of work and comply with those requirements. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management.
Capable of generating and/or revising Manufacturing specifications, procedures, and other technical documents for medical device products
Require a BS degree: ME, EE, IE, IT or equivalent education and experience
0 - 3 years’ experience in product documentation and manufacturing operations
Work in a med device environment required
Excellent written and verbal communication skills, must have good interpersonal skills and the ability work in a team environment
Excellent writing skills to author Engineering Change Orders with change descriptions, reasons, justifications, and supporting information
Experience in developing manufacturing assembly, test procedures and product structures
Must be proficient in the use of personal computers and Microsoft Office (Excel, Word, Visio, and MS Project (PowerPoint)) and Adobe products
Must be able to understand engineering drawings, Bills of Materials, and operational procedures
Ability to assess and resolve multiple high visibility problems timely
Familiarity with ISO 9001 and 13485 standards
Broad experience supporting complex medical devices and many of the following commodities or supplier types: lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCA’s, plastics, power systems, product packaging, turnkey subcontractors, hardware, labeling
Proficient with Pro-E, AutoCAD, or SolidWorks
Experience leading meetings both in-person and virtual
Daily working knowledge of SAP product documentation system and lifecycle management (engineering changes)
Experience presenting to large and diverse types of audiences
Effective organizational, planning and prioritization skills
“Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.”
Primary Work Location
USA CA - San Jose
NA (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.