1. Ronald H. Lee
rlee9589@charter.net
Areas of Expertise: Lean and Six Sigma, Process Improvement, Cost Reduction, Material Procurement,
Agile PLM & Agile PPM, Supply Chain, Oracle, SAP PPM, Value Analysis, Supply Chain & Process Mapping,
ITIL, Supplier Verification & Validation, Track Wise, CAPA, Material Program/ Project Management, ISO 9001:2015.
Executive Summary:
Five years as Part of Design Teams from product inception through commercialization and beyond based on feedback
from the field. Located, audited, and certified supply chains, which are FDA 13485 & 21 CFR Part 11, Conflict Materials,
and RoHS Compliant for Product Development Roadmap.
Developed material delivery schedules, maintained design history database, and material certs that supported product
builds from design concept through entire product life cycle.
Provided technical, Lean Sigma, and Business Support for cross -functional teams for Value Improvement Projects &
Products (VIPs), RFQ/RFPs, Procurement, Verification & Validation, supplier selection assessments, and NPI support.
Selected Accomplishments:
Identified and drove $1.8 million cost savings during initial ten months at
Boston Scientific improved supplier product quality and conducted make vs buy decisions, shortening the
supply chain, and selecting alternative suppliers.
Achieved $95,000 in savings in 2008 from supply chain improvements during product transitions and driving
supplier processes improvements.
PROFESSIONAL EXPERIENCE:
Thermo Fisher Scientific, Sunnyvale, CA
Environmental Compliance Programs Manager (Contractor) October 2015 – October 2016
Accountable to the Business Unit’s compliance to RoHS, REACH, WEEE and applicable environmental
product regulations as they emerge. Managed component engineer and supplier.
Researched and interpreted the regulations, directives and applicable laws and provided practical guidance to
Management, R&D, and Operations teams to establish and maintain compliance to ISO 9001:2015.
I am responsible for setting policy and strategy for evaluating and procuring components and products to
ensure
they will meet applicable regulations and Directives. I developed and maintained competence, capability and
adequate capacity through a combination of internal and 3rd party resources.
Maintained prioritized plans and schedules, and provided reporting for management, including progress, risks
and mitigation recommendations. As the Environmental Compliance Programs Manage. I assessed new and
emerging requirements and recommended compliance strategies to management to avoid disruptions of trade.
Established and maintained overall compliance strategies for the business unit.
Worked to maintain awareness of applicable standards and regulations; interpreting and reporting impact on
the
business unit with risk based recommendations.
Interfaced with outside agencies to maintaining current and future compliance status, communicating
internally and proactively lead cross functional projects to meet regulatory requirements.
2. Janssen J & J Fremont, CA
Senior Program Manager (Contractor) January 2015 – Sept 2015
Deliver Procurement-based competitive advantages. The development and managing of sourcing for material
prototype analysts and by providing category analytics & metrics.
Developing partnerships with Category Directors enabling global analytics across all category strategies.
Assessed current supply base, identified operational requirements, and negotiated strategic supplier
procurement agreements.
Managed team of three analyst(s) to include performance management and adherence to all policies and
procedures.
Supported Supplier Relationship Management processes by providing content, managed logistics and day-to-
day escalations.
Developed corrective action plans to improve metrics and category strategy.
Facilitated proactive contract expirations and renewals including the development of negotiation and
agreement strategies.
Conducted root cause analysis and develop corrective action plans for mismatches, invoice-in-hand, use of
non-preferred suppliers, and increase spend with diverse suppliers.
Hospira, Inc., San Jose, CA
Program Manager (Contractor) August 2013 –September 2014
Accountable for management of programs from concept through launch and responsible to ensure the teams
are on track following approved product develop, change, and quality plans.
Responsible for presenting issues, recommendations and updates to Senior Management in regards
to programs
Assists in developing strategies for specific product lines.
Provide project leadership on cross-functional team of supply quality engineer, buyer, and compliance
professional defining clear, realistic goals; clear barriers to ensure team progress, and facilitate rapid
decision-making. This includes the following:
o Change Management and Risk Assessment Plans,
o Identify and delegate action items, follow-up/track action items to resolution, update project
plans & deliverables, an, as required, identify and resolve issues off-line
Develop and execute on cross-functional communication plans. This includes meeting schedules (Agile
& Microsoft Project), meeting minutes, and other management updates as required.
Assure compliance to Design Control requirements.
Assure completeness and accuracy of project Design History Files. This includes coordinating/auditing
product documentation to ensure compliance and product quality, CAPA Resolution and Closure
Manage project timelines, budgets, and risks (Agile & Microsoft Excel and Project).
BOSTON Scientific, BSC, San Jose, CA (Medical Device Manufacturer)
Materials Project Management (Promotion) September 2011 – March 2013
Lead programs and projects via Materials Department with a focus on NPI (New Product Introduction),
improving supplier quality, procurement, prototypes, and performance. Developed and drove Value
Improvement Projects (VIPs), Supplier Development Projects, manage). Determined CM capability to meet
component and/sub-assembly project cost and budget targets (Microsoft Excel and Project) and to produce
released designs and negotiated requirements with marketing, and engineering to develop long-term product
procurement strategy. Lead multiple disciplines and functions as a team leader.
Interface with R&D on material procurement, cross-functional teams, managers, and senior
management to
meet project build and release milestones, deadlines, and strategies.
Worked with QE, Purchasing, senor prototypes and other supply chain operations, identify gaps and
improvement opportunities in the material process.
3. Supplier Development
Managed high-risk materials team of supplier quality engineer, process, plastic, process engineer and two product
inspectors.. Facilitate and managed supplier verification &validation, senor prototypes,
and qualification for new prototypes and component suppliers for PLM.
Manage the transfer of complex components between suppliers and transfer to our Costa Rica facility
(Agile, Excel and Project).
Scheduled QC and assembly operations, CAPA Resolution and Closure, scheduled manufacturing partners,
and suppliers (Agile, Excel and Project).
Planned, managed, and scheduled material for prototype builds (inventory management in SAP); collaborate
with internal groups such as Procurement, Supplier Quality Engineering, Logistics, Finance, Manufacturing
Engineering, Component Engineering and Quality Engineering.
Used Six Sigma methodologies at BSC & Opti Solar to build supplier "value stream maps.”
Worked with BSCS suppliers forecasting components and sub-assemblies to build up “BSC S&OP”.
Built supplier trust to eliminate “material shortages, shortage lists, and line downs and greatly improved in
inventory turns.
Product & Technology Development
Direct team activities, establishing task priorities, scheduling, sensor prototypes, and ensuring the availability of
resources
(Microsoft Excel and Project).
Lead and provide supplier development support to develop new process technology and ramp of new product
development (PLM) projects.
Commodity TeamSupport
Developed transition plans for Supply Chain Business Plans, verification & validation, and for commodity teams
Provided technical and business support to Value Improvement Projects (VIPs), RFQ/RFPs, supplier selection
assessments, senor prototypes, and NPI support.
Value Add and Principle Six Sigma Supply Engineer February 2009 - 2011
Engaged Plant Value Stream operations to identify and implement cost reduction opportunities, senor
prototypes in materials as they related to supplier rationalization and upstream or outsourcing transfer
of material to suppliers.
Managed cross-functional teams in the executing critical supplier improvement/cost reduction
initiatives.
Principle liaison between product development, quality engineering, CAPA Resolution and Closure.
production, marketing, field service, and suppliers to assure specifications, acceptance and testing
criteria clearly identified, documented and agreed to by all parties.
Provided technical and strategic support to commodity leaders related to buy transitions and
understanding supplier price increases.
Identified and lead transition projects of new and second sourced suppliers.
Make/buy analysis, actively involved in implementing supplier process improvements.
APPLE INC., Cupertino, CA February 2005 – February 2009
Senior DFX Engineer
Mechanical design for “everything”: manufacturability (DFM).
Serviceability, testability, managed team at Foxconn supplier consisted of three quality inspectors, 12
assemblers, four ME’s, two process engineers, and four buyers.
DF(x) where ‘x’ is any variable)! Evaluation of product designs via UniGraphics
Analyzed design for manufacturing processes and procedures, cost reduction and quality. Planned,
developed NIP schedules (PLM), created assembly planning, and design fixtures for assembly.
Provided technical support to suppliers and processing suppliers. Directed purchasing of tooling and
fixtures to support assembly operations.
Provided technical and processing SPC (Statistical Process Control) support to suppliers.
Leveraged quantitative data, CPK/PPK & SPC techniques as basis of input for product design
Changes, mfg. and improvement. NPI support throughout all phases of PLM.
Monitored and analyzed EM internal performance data to score per ISO Standards (ISO9001).
Assessed supplier for Select Supplier Program (SCM). Developed supplier quality control policies and
AQL sampling plans.
4. Identify and analyze EM cost variances to determine RCCA, and product manufacturing.
MOTOROLA, INC., San Jose, CA 2004 - 2005
Product Quality Engineer (Contractor)
Transition products from assembly and test at Motorola-BCS, to an EM (external manufacturer), managed a
complete “box build” at supplier which included supplier three quality inspectors, 8 assemblers, two ME’s,
process engineer, and two buyers.
Managed day-to-day manufacturing engineering operations activities.
Analyze contract changes from customer and effect of changes on existing and future work.
Managed EM to quote on and off AVL suppliers with qualification plans as required.
Negotiated requirements with product marketing, engineering, customers etc. to develop long-term product
supply strategy. Quote product assembly and test (manual, ICT, AOI, and functional testing), developing and
implementing supplier product quality triggers, metrics, and supplier score carding.
Work closely with product design engineering to develop clear understanding of product performance and
functionality about regulatory test requirements.
Reviewed all product engineering documents, BOMs, and ECOs’ (Engineering Change Notices) and
procurement for impact on inventory and implementation.
Experience with product compliance regulations (e.g., EU RoHS, EU WEEE) and industry standards.
Defined test plans with design engineering, coordinated regulatory testing, certification effort and maintained
certification records.
SUN MICROSYSTEMS, INC., Newark, CA 1997– 2003
Supply Product Manager
Managed continuous improvement of technical aspects of CQAT Cost, Quality, Availability, and
Technical).
Functional team included supply quality engineer, buyer, four assemblers, and a quality engineer.
Technical evaluation and qualification of suppliers and components.
Maintained metrics for process improvement, supplier management, and management.
Approved technical aspects of supplier evaluation, material component qualification, EM quality report
card, and defined and implemented product quality goals.
Verification & Validation, Qualification and audit of suppliers.
Used SAS & Minitab for SPC/SQC. Defined and developed metrics to track supplier product quality.
Extensive NPI support throughout all phases of PLM at EM (Suppliers).
Managed and drove the development, implementation, and reliability testing of repair processes at
Sun’s major EM Celestica.
Provided technical support to machine suppliers and processing suppliers.
Conducted quality (MIL, AS, and ISO) and manufacturing surveys to secure on time quality product.
Developed and monitored the project plans and project budget.
Experience with product compliance regulations (e.g., EU RoHS, EU WEEE) and industry standards.
Supply Project Engineer
Managed engineering initiatives from phase development life cycle (PLM) per engineering standards.
Managed supply chain cost, quality, and availability of commodities (inventory management in Oracle),
and services procured from the supply chain including distribution planning, production planning,
procurement simulation, customer communications and product forecasting.
Developed and negotiated contracts to second source component suppliers, decrease costs, and
increase material availability.
Experience driving product compliance to regulations (e.g., EU RoHS, EU WEEE) and industry
standards.
Noted and analyzed cost/schedule variances to determine cause, program impact, corrective action,
and
recovery date.
Education
Master of Business Administration (MBA) (Business Admin. & Finance), Golden Gate University
5. Bachelor of Industrial Engineering (BIA) Kettering University (General Motors Institute)