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Manufacturing Engineering: Process Development and Operations Consultant

Technical Consultant #2449


Expertise

  • Manufacturing process development: streamlining, characterization, optimization and validation (IQ,OQ,PQ,TMV,DOE) practices.
  • Strategic vendor and contract manufacturing (CM) partnership and streamlining of implantable device manufacturing technology and transfer process.
  • Interacted and represented department during regulatory audits, including FDA, and TUV.
  • Diversified experience in Medical Device, Aerospace, automotive and consumer products industries.
  • Equipment life cycle process including PM program, database improvement, define means to enable, sustain and measure the ongoing performance.
  • Research and development in product design and modification, ensuring manufacturable and cost efficiency.
  • Strategic initiatives for new therapies and market expansion including technology, innovation, supply chain, capacity and COGS analysis.
  • Regulatory audits, including FDA, TUV, and third party.
  • Design for Manufacturability (DFM), Six Sigma hands on and applications.
  • Perform engineering trainings and employee development.

Experience

Undisclosed Company, Director of Manufacturing Engineering, 2014 - Present

  • Streamlined process in manufacturing specific to: Development, characterization, optimization and validation (IQ,OQ,PQ,TMV,DOE) practices.
  • Strategic upgrade and integration of equipment life cycle process including PM program, database improvement and defined means to enable, sustain and measure the ongoing performance.
  • Liaison for strategic vendor-CM partnership and streamlined implantable device manufacturing technology transfer process.
  • Interacted and represented department during regulatory audits, including FDA, and TUV.
  • Promoted ongoing problem solving, process improvement and DFM culture across various departments.
  • Partnered and supported research and development in product design and modification to assure manufacturable and cost-efficient outcome.
  • Collaborated and advised leadership on strategic initiatives for new therapies and market expansion including technology, innovation, supply chain, capacity and COGS analysis, using well versed blend of technical, leadership, business and financial acumen.
  • Developed operations expenditure and capital equipment budget and maintained within 7% variance.
  • Managed and accountable for various aspects of operations including production, equipment, facilities and materials.
  • As cultural change agent to promote a positive and dynamic environment and establish departmental credibility.
  • Member of Strategic Planning and IP review Committee.
  • Executed talent acquisition, development and succession planning and built a high performing team.

Boston Scientific Neuromodulation,(BSN) Valencia, CA, 2013 - 2014

  • Fulfilling various positions: Senior Manufacturing Engineering Manager, Site Technician and VIP Lead
  • Lead Manufacturing Engineering department focused on; sustaining, logistical and NPD projects for implantable and externals production units of $70 million value of production with direct and dotted line report team of up to 10 engineers and technicians.
  • Develop, support, analyze VS strategy scorecard for scrap, yield, capacity, cycle time, standard. Cost and cost reduction.
  • Initiate lead and awarded various CAPA and $100K VIP (Cost Reduction) project teams, incl. 2.6% IPG scrap reduction resulting $736k annual savings as well as cycle time reduction and labor efficiency initiatives.
  • Provide technical and leadership support in various ongoing sustaining manufacturing initiatives, commodity and supplier strategy, including process improvement, problem solving, lean and line layout, vendor interaction, field complaints and various mfg. root cause investigations.
  • Perform engineering team expansion by talent identification and recruitment, employee development planning and cross training.
  • Completed various managerial and leadership courses at BSC including Leadership Development Program and Leadership Foundation.

Manufacturing Engineering Lead and Site Technical Lead, 2010 - 2013

  • Engineering Manufacturing Lead for Value Stream (VS) of $15 million value of production (sustaining and new product).
  • Led various projects and teams in support of Value Stream including ATE system design and development/validation.
  • Site technical lead and mentor for 6 Sigma programs. Developed, executed site strategy, and certified Six Sigma trainer.
  • Manufacturing engineering support to Spectra system development, launch, vendor development, and vertical integration projects.
  • Instructed various courses (Certified trainer and mentor) to employees on applied stats, 6 sigma and various topics.

Principal Mechanical Design Engineer, 2008 - 2010

  • Conducted and developed engineering analysis, reports, manufacturing documentation including technical specifications, process work instructions, tooling, fixtures and test equipment design, and BOMs for new product development projects.
  • Conducted manufacturing, financial acceptance analysis and report and present Readiness Review results to top management.
  • Engineering support of PCB/PCBA Design for Manufacturability (DFM), and vendor process audit activities.
  • Supported Process Mapping and Validation, Lean Six Sigma and Kaizen events and production facility move projects.
  • Performed use, design, product and process risk assessments for medical devices per Mil-STD 1629.
  • Designed and submitted 2 patent applications for manufacturing assembly tooling.

Senior Quality and Reliability Engineer (Advanced Bionics, BSC Company), 2006 - 2008

  • Developed quality and reliability test plans (QTP/QTR) and design, Verification and Design Validation (V&V) for medical devices.
  • Managed root cause analysis of field failures for implantable and non-implantable medical devices.
  • Reliability analysis and prediction, life tests, MTBF based on Mil-HDBK 217, Mil STD 883 and HALT/HASS.
  • Developed ongoing reliability performance metrics and complaint trending and co-chair of Reliability Leadership Team to define the reliability improvement priorities.
  • Support development teams in analysis of field failures.
  • Lead team of engineers and technicians in failure analysis of mechanical and electronic assemblies.
  • Implemented source inspection, developed CTQs and process controls to resolve national/int'l suppliers' issues.
  • Drove process improvement projects based on CAPA, including DOE for wire bonding and adhesion processes.
  • Provided quality engineering support to production, inspection and process verification and validation (IQ/OQ/PQ).

Integrated Magnetics Inc., Culver City, CA, Program/Project Manager - Chief Engineer, 2006

  • Responsible for contract mfg. projects; incl. design, tooling, materials, process controls, supplier qualification, testing, cost control, first article inspections, scheduling and technical liaison with customers and vendors.
  • Preparation and analysis of technical proposals up to $20 million for mechanical and electromechanical systems.
  • Developed BOM, routers, work instructions, drawings, conducted form, fit, function and Tolerance Analysis.
  • Managed program team of 6 including; sales engineer, buyer, planner, estimator, QE and CSR for projects over $4 million.
  • Conducted design review, DFM, DFA, design to cost, NPD, ECO and customer concurrent engineering.

Product Assurance Manager and Quality Engineer, 2005 - 2006

  • Handled Quality Planning of Aerospace, semi-conductor, medical and commercial products, for customers such as; Honeywell, Boeing, Applied Mtl's, J& J, Lockheed Martin, Moog, Tyco, ABB, Eaton etc.
  • Performed machinery capability study, SPC, Gage repeatability and reproducibility and DOE for CNC machining.
  • Special projects; weld leak test reliability, magnet mapping, search coil, material handling, saving $200K.
  • Designed and implemented integrated database for Supply Chain Management, Quality costing and inspection.
  • Handled MRB, NPD, Change Board, internal audits, contract reviews, lean and problem-solving projects.
  • Technical supervision and training for up to 10 inspectors on inspection plans and equipment.
  • Interfaced supplier and customer quality issues, specifications, CARs, SCM scorecards, kept 98.5% OTD, 1.1% scrap.

Markland Industries, Inc., Santa Ana, CA, Quality Assurance Manager, 2004 - 2005

  • Managed customer quality system, RMA process for; GM, Harley Davidson, Honda, and Kawasaki.
  • Redesigned GM and Harley Assembly line using lean techniques that resulted in 30% efficiency.
  • Managed QEs, coached 15 QC inspectors, trained manufacturing staff of up to 300 and supplier chain liaison up to 30.
  • Supported Engineer for the lab and environmental departments in tooling, prototyping, testing and process control.
  • Improved plating process yield by 5% using Statistical Process Control (SPC).
  • Pursued ISO/TS 16949 project, including FMEA, SPC, GR&R, APQP and PPAP for automotive industry.

Conveyor Systems, Inc., Pomona, CA , 2001 - 2004

Industrial-Manufacturing Engineering Manager

  • Managed material handling system design and manufacturing projects up to $1 million., for Costco, Nestle, and Kraft.
  • Managed operations and logistics, including procurement, quality, customer service, shipping and receiving.
  • Supported management, by providing cost estimates, financial analysis, accounting reports and budgeting.
  • Designed and developed engineering drawings, documentation and standard library.
  • Implemented companywide management information system (MIS), resulting in 20% realized cost savings.

Boukhan Industrial Corp., Tehran, Iran, Quality Assurance Manager, 1998 - 2001

  • Management representative in quality system and chair of ISO 9000 steering committee.
  • Implemented quality system based on ISO/QS 9000, achieved international automotive quality certification.
  • Started-up QA, QC and Training departments and managed staff including 4 engineers and 2 inspectors.
  • Reorganized structure including job descriptions, training needs, task matrix and reward system.
  • Managed the test equipment calibration program, designed and developed reliability testing equipment and SOPs.
  • Supported material and capacity requirement planning (MRP/CRP), SCM, RFQs, contract reviews and budgeting.

Senior Quality Engineer, 1997 - 1998

  • Designed and implemented Automated MIS, QIS and PM systems, resulting in 10% increased productivity.
  • Implemented SPC and Six Sigma projects for metal forming, and DOE for heat treatment processes.
  • Developed SOPs for NPD, engineering specifications inspection and test plans, FMEAs and control plans.
  • Conducted stopwatch based Time Study projects to provide standard time and cost data.
  • Supervised and conducted 300 hours training for QC inspectors per Mil STD 105, ANSI Z1.4.

Saravel Corp., Tehran, Iran, Quality Control Engineer 1995 - 1997

  • Implemented SPC, Six Sigma and P.A.F. based Quality Costing (COQ) systems in HVAC industry.
  • Publication of ISO 9000 and Statistical Process Control (SPC) training material.
  • Conducted ISO 9000 quality system internal and external audits.

Honors & Publications


Credentials

  • Project Management Professional (PMP) - PMI
  • Certified Lean Six Sigma Black Belt (CSSBB) - ASQ
  • Certified Reliability Engineer (CRE) - ASQ
  • Certified Quality Engineer (CQE) - ASQ
  • Certified Quality System Lead Auditor (CQLA) - QMI & RW-TUV
  • Certified Quality System Auditor (CQA) - IRCA

Languages

  • English (Fluent)
  • Armenian (Fluent)
  • Farsi (Fluent)
  • German ( Read, Write, Conversation)
  • Spanish ( Read, Write, Conversation)

Academic and Professional Affiliations

  • Member of Society of Manufacturing Engineers (SME)
  • Member of American Society for Quality (ASQ)
  • Member of Armenian Engineers & Scientists of America (AESA)

Awards

  • NASA Tech Brief Design Contest, awarded, for concept design of an everyday product.

Publications

  • Author of a publication addressing Quality Improvements (C.O.Q.)

Education

  • MBA Business Administration (Cum Laude), California State Polytechnical University, Pomona, CA
  • M.S. Industrial-Manufacturing Engineering, Azad University, Tehran, Iran
  • B.S. Industrial-Manufacturing Engineering, Azad University, Tehran, Iran
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