Title: Manufacturing Engineer II
Location: San Jose, CA
Contract Term: 12+ Months
Weekly 40.00 hours
Work Shift: 1st Shift 8am-4pm – onsite
Interviews: Phone interview first, then In person Interview
We need to have these questions answered during the submittal process:
1. Do you have a degree in Electrical or Mechanical Engineering?
2. Do you have Medical/Pharmaceutical work experience?
3. Can you read electrical schematic and mechanical engineering drawings?
4. Are you familiar with Oscilloscopes and Digital Multi-meters? Please provide specific examples
5. Do you have experience creating Engineering Change Orders (ECO)? Please provide specific exampls
***My target candidates are the one with following degrees from Medical /Pharmaceutical industry:
Potential Contract to Hire.
Work Shift: 1st Shift 8am-4pm (United States of America)
•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. Strives to continuously improve processes in order to achieve optimal efficiency for manufacturing operations.
•Supports the introduction of new products into manufacturing. Reviews engineering designs and documentation for completeness, clarity and manufacturability. Evaluates and qualifies new suppliers. Interfaces with Product Development to define and implement manufacturability criteria, develops procedures/processes for assembly, PCB's, systems and sub-systems test procedures including fixtures, during the development process. Ensures designs, documents, and procedures have been validated in manufacturing prior to production release.
•Assesses feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data is insufficient or confirmation by testing is advisable.
•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.
•The M.E. may perform and document field failure investigations, identify root causes, and participate in corrective and preventative action efforts.
•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.
•Performs other related duties and assignments as required,
•BS degree: ME, EE, IE, Physics or other Technical degree.
•3+ years experience in a high tech manufacturing 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 extensive experience writing and reviewing Engineering Change Orders
•Must have strong 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.
•The ability to successfully interact with executive management
•Ability to be effective with minimal direction. Recognizes problems and addresses them without waiting to be instructed to do so
•Familiarity with ISO 9001 and 13485 standards
•Willingness to travel frequently
Additional And Preferred Qualifications And Skills
•Proficiency with some of the following applications: Pro-E, AutoCAD, SolidWorks, MS Project, MS Access, SAP ERP, Visio,
•Experience resolving technical issues involving lasers and optical components
•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
•Strong cGMP familiarity 21 CFR part 820, medical industry experience
•Experience implementing Demand Flow Technology (DFT) processes
•Experience implementing LEAN manufacturing processes
•6 Sigma green or black belt
Looking for some stability with work history