Manufacturing Engineer Urgent Need

Position : Manufacturing Engineer

Location : San Jose CA

Duration : 12 Months contract

Total Hours/week : 40.00
pay rate-$20-30/hr

1^st Shift

Client: Medical Devices Company

Level Of Experience: Mid-Level or Senior Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Work hours: 8AM 5PM

3 Must haves on the resume:

a. Must be proficient with SolidWorks Oscilloscope and Engineering Change Orders

b. Must be familiar with ERP SAP system Agile or the like and Electro-Mechanical assemblies PCBAs & Sheet metal experience and have troubleshooting experience with instrumentation devices.

c. Must have Medical/Pharmaceutical industry experience

Job Description:

• The Senior Manufacturing Engineer (ME) will be expected to simultaneously lead multiple high impact projects.
• The ME is expected to lead change contribute new ideas and find innovative methods to accomplish goals. Works on complex mechanical/electrical/electronic problems where analysis of situations or data requires an in-depth evaluation of various factors. Acts independently and exercises judgment within broadly defined practices and policies. May supervise the activities of others.
• Determines methods and procedures on new assignments. The ME will be expected to have the ability to get things done through people that do not report to them.
• The ME will also need to have the ability to work through adverse situations while building and maintaining good personal relationships.

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.
• Follow proper document formats material and description nomenclature and correct SAP data types per company standards.
• Coordinate with various functions for change review and impact analysis ensuring cross-functional requirements are identified and understood for affected items personnel and processes.
• Lead cross functional project teams to optimize product design qualify replacement components improve manufacturing operational efficiency product quality customer satisfaction and reduce manufacturing costs.
• Capable of solving and determining root cause of difficult technical issues encountered during assembly and test of production assemblies.
• Must be able to implement effective solutions in a timely manner to resolve mechanical optical electrical and fluidic issues.
• Support the introduction and transfer of new products into manufacturing. Review engineering designs and documentation (drawings & specifications) for completeness clarity and manufacturability.
• Evaluate and qualify new suppliers. Interface with Product Development to define and implement manufacturability criteria develop procedures/processes for assembly PCBs systems and sub-systems test procedures including fixtures during the development process. Ensure designs documents and procedures have been validated in manufacturing prior to production release.
• Conduct field failure investigations identify root causes and participate in corrective and preventative action efforts.
• Keep abreast of the basic requirements for compliance. Participate as required in training on regulatory issues affecting own area of work.
• Bring regulatory compliance questions/issues to the attention of management.
• Performs other related duties and assignments as required

Qualifications:

• BS degree: ME EE IE Physics or equivalents
• At least 4 years of experience in a high-tech manufacturing environment
• Experience sustaining and troubleshooting electro-mechanical devices/equipment
• Must be proficient in the use of personal computers: SolidWorks (CAD) MS office (Word Excel Power Point Project Visio) Adobe
• Familiar with Enterprise Resource Planning (ERP) SAP Agile or the like
• 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 when required

Preferred Skills and Qualifications:

• M.S. degree
• Proficiency with some of the following applications: Pro-E AutoCAD
• 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 PCAs 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