Engineer Process
Resume:
Kimberly Cue
Santa Clara, Ca *5051
********.***.***@*****.***
Education:
Liberty HS; Graduated Valedictorian
Scholarship from Dow Chemical, for BS in Chemical Engineering (equ)
Specializing in Process Engineering
Qualifications Profile:
Detail oriented and professionally prepared to excel in the field of engineering utilizing my
experience and contribute to organizational objectives.
Pacific Die Cut Industries 2013-Present :: Sr. Quality Engineer/FDA Regulatory Specialist
o Created Process and form for APQP and trained PMs
o Create drawings for production and suppliers
o Write manufacturing and test procedures and documentation
o Perform process capability studies
o Support manufacturing engineering activities such as process development and fix ture design
o Assist with tool design
o Train operators and provide technical support
o Conduct root cause and corrective action implementation
o Submitted SCARs and closed SCARS received; submitted/closed out ICARs
o Perform validation on new tools and processes
o Successfully implemented 5S in 2 manufacturing plants and in clean room
o Conducted Continued Quality Improvement classes to improve process, identify cost
reductions/savings, and improve on manufacturing safety
o Lead Internal Audits for ISO 13485 and 9001
o Federal Regulatory Specialist (REACH, RoHS, FDA Software Validations, OSHA, etc.)
o US/IDE 510(k) audits for our customers
o Identify and submit FDA registration requirements and monitor fiscal fees
o Managing FDA FURLS accounts
o Confirm FDA classification (1,2 or 3) in regards to 510(k) approvals/exempt from 510(k)
o Monitor FDA recalls for products made internally
Brooks Automation 2012-2013 :: Manufacturing/Project Engineer
o Provides leadership and have designed metrics for OTD.
o Fluent with creating Control Plans
o Create drawings for production and suppliers
o Reduce costs by improving product reliability
o Monitors effectiveness for production to increase quality and process improvement.
o Experienced in project planning, scheduling, and budgeting as well as managing client and
subcontractor relations, project forecasting, profitability targets and proper close out of multiple
projects
o Recommend design improvements to R&D and redlining P&IDs
o Assist in making contact and researching customer needs through modifications of standard
systems CAPAs - SCAR/ICARs/FAs/DOEs
o Identified and implemented and KPIs and SPCs
o Led teams in FMEA/DFMEA to show the trends and the failures modes based on findings to
improve on design/processes/material integrity
o Manage the Material Review Board to ensure ECOs are processed by Engineering Group and
vendors have current drawings.
o Lead auditor in conducting Internal Audits monthly to ensure various departments are following
company processes.
o Conducted Continued Quality Improvement training classes for Engineering and Production and
monitor improvements for effectiveness
o Initiated, submitted and implemented ECOs
o Created Process, Implemented and Manage TPM criteria in production, created tracking
documents & procedure then trained engineering on new process.
o Assist in vendor selection
o Manage the awarding of outside facilities contractors and audited performance
o Enforce safety policies and procedures with the goal of achieving zero incidents, lost time
injuries, property damage, and claims
o Assist in the supervision of operations and equipment, including the support of field staff in
daily dispatch request for crews, materials and equipment.
o Oversee monthly progress billings and subcontractor payments
o Monitor/mentor intern Engineers
o Review and approve purchase order commitments for job specific purchases
Intandem, Inc. Senior NPI Engineer :: 2006-2010
o Ensured smooth system integration and product introduction at the core team level via APQP
Process
o Provide support to the Supply Chain Management organization
o Implemented product changes and related tooling and equipment per ECO process
o Troubleshoot and direct manufacturing personnel on repairs/refurbished RMA and RP materials
o Investigated, proposed, justified, planned and implemented cost savings to existing pro jects
o Assisted in qualifying vendors to establish cost effective solutions to new projects
o Understand and interpret key elements of USA standard, and the ability to apply and comply
with statutory legislation and regulations.
o Participated in vendor audits as required.
o Assisted in FDA 510(k) submissions
o Performed various quality training sessions to ensure that the product, traceability, reliability and
quality goals are achieved
o Supported preliminary project schedule
o Examines performance requirements of material, equipment, and production to ensure
completeness and accuracy.
o Designed visual work instructions and trained production inside/outside of clean rooms.
DES, Inc. Chemical/Process Engineer :: 2003-2006
o Assisted in Preparing bids, process specifications, test and progress report s
o Conducted testing protocols
o Test methods and analyzed the results
o Managed equipment and process issues
o Maintained accurate documentation and revision levels of concepts, P&IDs, drawings and
schematics
o Developed equipment procedures for testing and characterizing performance
o Developed and implemented operational procedures to provide easy to follow assembly
instructions
o Supported related R&D technical efforts on a low pressure, low temperature vacuum pres s used
primarily for recycling waste water and separation of oil sands
o Support cross functional / Training
o Communicated and adhered to company procedures and regulatory requirements
o Created visual work instructions for production and preventive maintenance on process equipment
o Tested and calibrated instrumentation when needed.
Dow Chemical: Chemical & Process Engineer Intern :: 2000-2003
o Assist with project execution, trade coordination, scheduling, document management and problem
solving
o Estimating and proposal writing
o Evaluated pump and compressor efficiencies in every plant at Dow Chemical to ensure processing
at the pumps/compression curve for maximum energy efficiency
o Evaluated process efficiencies such as the heat transfer rate across the tubes on a tube and shell
heat exchanger to evaluate build up there are on the tubes (or on the plates for the plate & frame
hex)
o Calculated the reflux ratios on the distillation towers to ensure Dow is manufacturing the correct
wt% of product per customer requirements
o Built proto process block for mass transfer of liquid process
o Calculated the delta pressure in evaporators in Dows refrigeration loops
o Calculated irreversible zero order, first order, second order and pseudo first order – batch, plug
flow, constant flow stirred tank and catalytic bed reactors for efficiency and calculating the rate of
consumption and the heat rate of a reaction to elevate the chances of a run away reaction
o Used Stiochiometry to write a relationship between lb/gram moles of a chemical compound for a
multitude of reasons, i.e. neutralizing sumps
o Calculated pressure drop in a vapor system via Bernoulli’s Equation
o Calculated mass flow rate in a gas system in STP
o Solve for volumetric & mass flow rate
o Calculate vapor volume in ACF as temp increases
o Solving for volume of a solute
o Write replacement reactions.
Computers and Administration:
o Knowledgeable with standard desktop programs and operating systems including but not limited to
DowTran, Agile, Oracle, HQMS, Labview, Solid Works, AutoCad, ChemCad, Alliance, Windows
XP/Vista and the Microsoft Office application suite and Outlook.
Special Assignments:
o Intandem, Inc sub-contracted me out to one of their medical 13485 customers to assist in getting
their production department’s documents prepared for their FDA audit (in which they passed with
no findings).
ISO9001:2008 Internal Auditor Certified
ISO13485:2003 Internal Auditor Certified
Professional and personal references available upon request.
Compensation: Negotiable
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