Job Description

Job Description Summary

Perform manufacturing engineering tasks in a highly-technical manufacturing environment for complex medical equipment under a tightly-regulated industry, with a cost-sensitive approach, and a customer-oriented focus. Deliver quality, cost-competitive and on-time engineering solutions. Support launch of new products into the manufacturing group, and commercialize into customers' hands. Use manufacturing engineering tools of project management, risk analysis, engineering technical skills and knowledge, root-cause analysis, design-for-manufacturability, value engineering, value stream mapping, statsitical analysis, and DMAIC approaches.

Job Description

The ME 1 is expected to work on problems of moderate scope with general instructions, using judgment within defined parameters. The ME is expected to implement change, contribute new ideas, and find innovative methods to accomplish goals. The ME will need to have the ability to work through adverse situations while building and maintaining good personal relationships.

ESSENTIAL FUNCTIONS

* Provides hands on support to the manufacturing assembly and test processes for flow cytometry instruments. Resolves day-to-day production issues that may impede BDs ability to ship quality products on time.
* Must have the ability to solve problems, and determine root cause of 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.
* Strives to continuously improve processes in order to achieve optimal efficiency for manufacturing operations.
* Will serve as a member of cross functional project teams. Major objectives may include: product cost reduction efforts, designing processes to improve manufacturing operational efficiency, optimize product design, qualify replacement components, improve product quality, improve customer satisfaction, and reduce manufacturing costs.
* Supports the introduction of new products into manufacturing. Establishes processes and procedures, create assembly documentation. Reviews engineering designs and documentation for completeness, clarity and manufacturability. Develops and implements production tooling, test fixtures, equipment, and work cell layout. Participates in setting labor standards. Develops and implements strategies to optimize material and workflow.
* Performs and documents field failure investigations, identify root causes, and participates in corrective and preventative action efforts.
* Writes Engineering Change Orders, producing high quality documentation that is clearly understandable by suppliers and internal personnel and adheres to industry standard conventions.
* Work is usually independently performed with general instructions as to the objectives expected; Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
* Must be able to develop and maintain good working relationships with internal customers, primarily line level production personnel, other MEs, QA, Planners, Purchasing, Development and managers.
* Ensures that manufacturing procedures and appropriate levels of process control are in place and meet regulatory GMPs. Brings regulatory compliance questions and issues to the attention of management as necessary.
* 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 attention of management.
* 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 all observed hazardous conditions or unsafe work practices.

Minimum Requirements:

* Typically requires a BS degree: ME, EE, IE, IT or equivalent education and experience
* 1 + years experience in a high tech manufacturing environment
* Must be proficient in the use of personal computers: MS Word, Excel, Power Point, Windows or MAC OS, Visio, MS Project.
* Excellent written and verbal communication skills, must have good interpersonal skills: conflict resolution, negotiation, and the ability work in a team environment
* Must be able to understand engineering drawings, Bills of Materials, and operational procedures
* Must have experience writing and reviewing Engineering Change Orders
* Experience implementing continuous improvement solutions
* Experience developing manufacturing processes, writing procedures, and training assembly personnel
* The ability to assess and resolve problems in a timely manner.
* Ability to be effective with minimal supervision. Recognizes problems and addresses them without waiting to be instructed to do so
* Familiarity with ISO 9000 standards
* Willingness to travel infrequently

Desirable Qualifications:

* Project management experience
* Proficiency with some of the following applications: Pro-E, AutoCAD, MS Access, SAP ERP, Visio, Photoshop, and software application workflow automation.
* Experience resolving technical issues involving lasers, optical components, fluidic systems or digital/analog circuitry.
* Experience supporting some of the following commodities or supplier types: lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCAs, plastics, power systems, product packaging, turnkey subcontractors, hardware, labeling, bar code systems
* cGMP familiarity 21 CFR part 820, medical device manufacturing experience
* Experience implementing Demand Flow Technology (DFT) processes
* Experience implementing LEAN manufacturing processes
* 6 Sigma green or black belt

Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift

NA (United States of America)