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BD (Becton, Dickinson and Company) Manufacturing Engineer I in San Jose, California

Job Description SummaryThe Manufacturing Engineer (ME) is responsible for generating manufacturing documentation, processing change orders, supporting Instrument Operations Engineering staff. The ME will work with other functional groups, such as Document services, Quality, Regulatory Affairs, Research & Development, and other associates supporting new product development to prepare new and/or revised product documentation and master data in the business system for approval and implementation. Ensures required documentation for new materials is in place for initial builds and testing using the ECM process. Provides Regulatory and logistical guidance to ECR/O originators within Instrument Manufacturing. Works on complex mechanical and electrical problems where analysis of situations or data requires an in-depth evaluation. Exercise judgment within broadly defined practices and policies in selection methods, techniques, and evaluation criteria for obtaining results. May determine method and procedures on new assignments and may provide guidance to lower level associates.

Job Description

Duties and Responsibilities

Prepare, create, and maintain various types of documents such as drawings, quality documents and manufacturing specifications for BD products and services. Redline assembly, test, and specification documents for engineering change orders Work with cross-functional associates who are submitting and reviewing information for the preparation of various documents to ensure accuracy and appropriate format per company standards Initiate change orders, plan and coordinate the flow of new or sustaining product documentation with the contributors, signatories, and Document Control Specialists. Track and update the status of change orders Coordinate existing document and material revisions for Instrument Operations Manufacturing. Work closely with end users, stakeholders and Document Control Specialists. Track and update the status of the changes within Instrument Operations Generate and revise manufacturing and other technical documents and SAP master data Ensure all ECO changes occur in a timely manner and performs 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 Promote a safe work environment. May provide recommendation on maintaining the safety of the work environment. Participate in Environmental, Health and Safety programs. Address corrective actions whenever a hazard is identified. Notify supervisor of all observed hazardous conditions or unsafe work practices Exercise sound judgment within defined practices and policies for obtaining solutions Performs other related duties and assignments as required

Minimum Requirements:

  • Require a BS degree: ME, EE, IE, IT or equivalent education and experience

  • 0 - 3 years’ experience in product documentation and manufacturing operations

  • Must have extensive experience writing and reviewing Engineering Change Orders

  • Experience in developing manufacturing assembly and test procedures

  • Must be proficient in the use of personal computers and Microsoft Office (Excel, Word, Visio, and MS Project (PowerPoint))

  • Proficient with Pro-E, AutoCAD, or SolidWorks

  • Proficient in Adobe products

  • Must be able to understand engineering drawings, Bills of Materials, and operational procedures

  • Excellent written and verbal communication skills, must have good interpersonal skills: conflict resolution, negotiation, and the ability work in a team environment

  • Ability to assess and resolve multiple high visibility problems timely

  • Effective interpersonal, negotiating, problem-solving and analytical skills

  • Familiarity with ISO 9001 and 13485 standards

Desirable Qualifications

  • Broad experience supporting 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

  • Experience implementing LEAN manufacturing processes

  • 6 Sigma green or black belt

  • Experience leading meetings both in-person and virtual

  • Self-driven and detailed oriented.

  • Daily working knowledge of SAP

  • Experience presenting to large 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.”

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Primary Work LocationUSA CA - San Jose

Additional Locations

Work ShiftUS BD 1st Shift 8am-4pm (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.

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