Position: Senior Manufacturing Engineer

Location: San Jose, CA

Duration: 12+ Months Contract

Total Hours/week: 40.00

1st Shift: Work hours: 8AM – 5PM

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Seniority Level

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

No H1B’s

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 & Sheetmetal experience and have troubleshooting experience with instrumentation devices.
c. Must have Medical/Pharmaceutical industry experience

Summary
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, PCB's, 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, 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