This resume is for Robert Van Wert, an experienced quality and manufacturing engineer with over 15 years of experience in various industries including medical devices, semiconductors, and automotive. He has extensive experience with quality systems and process improvement methodologies including Six Sigma, Lean, design controls, and risk management. His background includes roles in quality engineering, manufacturing engineering, and process engineering with responsibilities such as developing manufacturing documentation, implementing quality systems, resolving non-conformances, and improving production processes.

1. Sr. Quality / Manufacturing Engineer
ROBERT VAN WERT
Morgan Hill, California 95037
Cell: 408-889-3158 Email: robertvanwert@charter.net
QUALIFICATION & SPECIALIZATIONS
 Experience in Manufacturing, Quality, Process, & Industrial Eng. dealing with class I & II medical devices,
computers, semiconductor, process & product development.
 Provided documents for Build Tree, Process Flow, DMR, DHR, SOP, MPI’s for medical and electro
mechanical devices using MS Word, MS Visio, SolidWorks, Power Point and Adobe Photo Shop.
 Experience with DFM, SPC, Cpk, Cp (Process Capability), root-cause analysis, Gage R&R, & DMAIC,
Six Sigma (Normality test) for finding solutions to problems & making improvements to the process.
 Experience in designing process flows, layouts, Design Controls, Value Stream Mapping, SolidWorks
drawings, NPI, DHF, DOE, GD&T, Supplier Audits, analyzing and solving bottle necks, line balancing.
 Production support for trouble shooting complex electro-mechanical systems & medical devices, CAPA
Certified, experience in 8D, 5S, 5W investigation of nonconformance’s (NCMR), disposition of material
(MRB) and finished products, Failure Modes Effect Analysis (FMEA).
PROFESSIONAL EXPERIENCE
Ecopia Farms (Indoor Organic Farming – Produce microgreen in Trays under LED’s)
Process Eng. & Project Manager (5/15 – 2/16).......……………………………………….....End of Contract
 Created & maintained MPI’s (Manufacture Process Instructions), design production layouts & supported
harvesting & shipping line processes. Performed Pilots Operations before going into full production.
 Design new automated watering application and growing tray.
Velodyne Inc. (LiDAR- Laser Imaging Detection & Ranging used to pilot self-driving cars)
Mechanical Engineer & Doc. Control (9/14 – 2/15)…………………………..……………….End of Contract
 Created 2D drawings from 3D model using SolidWorks, updated BOM
 Release NPI thru ECO process using Arena. Use PDM to control changes to SolidWorks drawings.
 Update MPI, Process Flow Chart, 2D mechanical drawings, created ECO to release updates
 Created Fixture used in the 32 bit LiDAR
Restoration Robotics (Medical – manufactures robots used for hair restoration)
Sr. Mfg. / Qlty Eng. (6/11 – 8/14)………………….……………………………………….………..Reorganized
 Liaison between CM regarding training, inspecting, assembling, testing, & ECO releases of NPI products.
 Submitted SCARS to CM and reviewed & approved CAR in response to SCARs.
 Applied IQ, PQ, OQ when transferring production line to Costa Rica & new CM.
 Design fixtures, tools, & jigs using Solidworks. Disposables setup in Costa Rica.
 Created BOMs, Build Trees, Flow Charts, MPI’s, and submitted ECN’s which released said items to
Engineering & Manufacturing using PLM software called Arena and Rite Pro.
 Applied Lean Six Sigma & 5S to identify waste, improve cycle time and Process Cycle Efficiency (PCE)
 Reviewed CAPA’s from CM that solved complaints from customers dealing with the needle clip.
 Used FMEA to address problems found during assembly and possibly in the field.
 Applied Design Verification & Validation to NPI (Chair, Mechanism, and Cart), upon released trained CM
 Managed & train CM to assemble, load software, test, and follow FDA 21 CFR 820, cGMP, & SOP.
 Performed audit on Optical & Camera Supplier to confirm they have the following: procedures for Mgmt.
Review, Personal Training records (job description & resumes), & CAPA’s
 Participated in CMB, MRB, NCMR Reports, 8D, SCAR’s, SOP, ECO, MPI, ECR, CAB, CAPA, & PLC.
 Used Fishbone diagram and Pareto analysis to solve problems dealing with the transformer noise.
 Applied Pareto analysis, CAPA and 8D concepts to problems dealing with the recessed ball detent.
Bio Mechanics (Medical – infusion pumps for I.V. fluids & medication administering drugs)
Quality Engineer (11/10 – 5/11)………………………….……………………………….......Division Relocated
 Applied metrics, monitor rework processes, analyzed trends reports on pumps being returned.
 Reviewed Risk Analysis and Corrective Actions dealing with power cord issues. NCMR, 8D, Kaizen

2. ABBOTT DIAG. DIV. (Medical - producing hematology analyzers, calibrators, & reagents)
Quality Engineer (12/06 – 10/10)…………………………………………..….Company Downsized
 Responsible for discovering errors on Assay Sheet before sending it out to customers.
 Supervise & documented Quality holds and Design Controls on IVD and reagents.
 Monitor trends & performed risk analyses on defective parts (NCMR).
 Used root causes analysis & implemented Corrective Action dealing with reagents & tube holder.
 Flow Cytometry - 3500, 3700, 3200, Ruby, 4000, Sapphire.
 Participant in CMB, creating Nonconformity Reports, SCAR’s, SOP, MRB, ECN, CAB, & CAPA.
 Review Verification & Validation plans on new parts or parts being replaced.
 Applied SPC to parts assigned to be sent to inspections coming from suppliers.
 Certified Approver in CAPA (tube dia.) Familiar with FDA reg. 21 CFR Parts 58, 210, 211, & 820.
ENTEGRIS (Mfg. pumps, containers, washers, & filters used in semiconductors)
Manufacturing Engineer (10/05 – 9/06)……….……………………………..…Division Shutdown
 Experience with Six Sigma, and Lean Manufacturing. Used 5S’s to organize cross-functional teams to
implement Lean Mfg. & solve problems associated with late shipments. Saved the company $86,000.
 Reduced failure rates on refurbish pumps by analyzing test criteria and environmental testing conditions.
Liaison between customers requesting RMA. Applied ISO 14971 Risk Management.
 Managed 9 people responsible for repairing highly complex cartridge pumps used to dispense chemicals
in the semiconductor industry. Created schedules, evaluations, setting safety stocks limits, tracked new
parts & orders. Setup Metrics to monitor process & analyze trends & improve process by getting rid of
bottle necks.
EMS (CM – System Integration, Metal Fab, Box Build & Burn-in & Test)
Sr. Process Eng. (6/04 – 9/05)……….……………………………..…………………Opportunities
 Supported contract manufacturing, participated in CMB signing & approving ECO’s, optimize
production flow by eliminating waste, Sustain & reduce cost of manufacturing through end of life.
 Implemented Lean Mfg. Principles (5S, Cp, Cpk, and SPC), resolved material problems, created
process and value stream maps, familiar with precision sheet metal.
 Responsible for assembly processes on several production lines dealing with enclosures, transition of
NPI, purchased tools, develop MPI's, release documents, approved ECOs (prints, MPI, BOMS, routers
– sequences, time, costs, scheduling), solved manufacturing & design problems, and improve yields.
JABIL CIRCUITS (CM - Mfg. PCB – Box Build - Semi-conductor)
Industrial Engineer (10/03 – 5/04)….…………………..……………..………Company Downsized
 Design production line layout, supported box build production, RMA’s, applied 5S to rid each area of
waste, improve yields and cycle time, develop MPI’s for customers.
 Develop test chamber for burning in finish product at elevated temperatures (stress test).
KLA Tencor (Mfg. large capital equipment used to fabricate & test silicon wafers)
Industrial Engineer (7/02 – 8/03)………………………………..………………………………End of Contract
PROGRAMS FAMILIARITY
 SolidWorks, PDM, ANSI  VISIO, Label Matrix, Google Docs.
 Excel, Word, Power Point
 Project
 Google Gantt Chart, Rubric, 6 Sigma
 MS Project, Mini Tab,  SAP, Baan, ASK, Rite Pro, Arena
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EDUCATION
ISO 13485 Implementation (QMS)(ASQ) BS in Industrial Eng.
21 CFR Parts 820 (QSR) CA State University, Chico
Six Sigma Training (Black Belt) Solid Works
Risk Mgmt. ISO 14971 (ASQ) Evergreen Valley College, SJ, CA
Design Verification & Validation (ASQ) AA in Electronics
Design Controls for Med. Dev. (ASQ) American River Jr. College, Sacto.