BD (Becton, Dickinson and Company) Staff Manufacturing Engineer in San Jose, California
Job Description Summary
The Staff Manufacturing Engineer (SME) is a key contributor within the Reagents Manufacturing department. The SME is expected to work on problems of moderate to large scope that require good judgement, with little management involvement. The SME will lead change, contribute new ideas, and find innovative methods to accomplish goals. In order to be an effective contributor, the SME will be expected to have the ability to get things done through people that do not report to them. The SME will also need to have the ability to work through adverse situations while building and maintaining good personal relationships.
Key member of and sometimes lead, cross functional project teams. Major objectives may include: improve manufacturing operational efficiency, optimize product design, qualify replacement components or suppliers, improve product quality, improve customer satisfaction, or reduce manufacturing costs.
Support the introduction of new products and equipment into manufacturing. Establish processes and procedures, create assembly documentation. Review engineering designs and documentation for completeness, clarity and manufacturability. Evaluate and qualify new suppliers. Train production personnel, oversee the efforts of more junior associates. Leads validation activities to include installation, operational and performance qualifications
This key position provides hands on support to the manufacturing, assembly and test processes for reagent operations. The SME resolves day-to-day production issues that may impede BD’s ability to ship quality products on time. Must be an adept and experienced problem solver who is able to determine root cause of difficult technical issues. Must be able to implement effective solutions in a timely manner. Issues are typically multi-disciplinary in nature: mechanical, optical, electrical, and fluidic. The SME will strive to continuously improve processes in order to achieve optimal efficiency for manufacturing operations.
The SME will perform and document field failure investigations, identify root cause, and participate in corrective and preventative action efforts.
Work is usually independently performed with general instructions as to the objectives expected; May receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of issues.
Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the leadership team.
BS degree: ME, EE, IE, IT or equivalents
12 years experience in a high tech manufacturing environment
10 years experience in a FDA or ISO regulated production environment
Must be proficient in the use of personal computers: MS Word, Excel, Power Point, MS Project, Visio, Windows or Mac OS
Excellent written and verbal communication skills, must have good interpersonal skills: conflict resolution, negotiation, and time management skills
Must be able to understand engineering drawings, Bills of Materials, and operational procedures
Must have experience writing and reviewing Engineering Change Orders
Must have proven project management experience, Led continuous improvement efforts with cross functional teams
Experience developing manufacturing processes, writing procedures, and training assembly personnel
The ability to assess and resolve multiple high visibility problems in a timely manner.
Ability to be effective with minimal direction. Recognizes problems and addresses them without waiting to be instructed to do so
Familiarity with ISO 9000 standards
Willingness to travel infrequently to support new production equipment
Proficiency with some of the following applications: Pro-E, AutoCAD, MS Project, MS Access, SAP ERP, PhotoShop.
Experience resolving technical issues involving vision systems, mechanical components, fluidic systems, digital/analog circuitry and software code
Strong background in manufacturing automation equipment for reagents including in-process verification methods such as vision systems and sensors. Knowledge of components and systems integration to create automated equipment
cGMP familiarity 21 CFR part 820, medical device manufacturing experience
Experience implementing Demand Flow Technology (DFT) processes
Knowledge in Six Sigma methodology and practices
Primary Work Location
USA CA - San Jose
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.