SUMMARY

• 20+ years of “hands - on” manufacturing engineering, technical writing, and operations management experience.
• Diverse industry experience includes complex drug discovery instrumentation manufacture, micro-fluidics, industrial genomics research consumables, biochemical reagent formulation, high technology consumer goods (printers and computer monitors), electronics (military communications, circuit board assy. SMT & through hole), process equipment troubleshooting, solar energy, and medical devices.
• GDP; 1) Batch records, work instructions, standard operating procedures, manufacturing assembly instructions (reformat and create), 2) software validation protocol, 3) master validation plan, 4) QA SOP’s (reformat), 5) molecular diagnostic lab assay SOP’s (reformat), 6) lab forms (reformat), 7) Confidential user manual chapters for Camstar MES training, 8) medical device regulatory summary reports from test procedures.

TECHNICAL SKILLS

Engineering skills: 1) new product introduction, 2) production line design & process flow diagrams, 3) process equipment troubleshooting, 4) sustaining engineering, 5) process improvement via SPC, 6) work measurement, 7) cost reduction, 8) facilities planning, 9) ECO cost estimating

Software skills: 1) MS; Word, Outlook, Excel, Visio, Project 2) Agile PLM, 3) Camstar MES, 4) EtQ, 5) ProE Windchill, 6) Adobe Photoshop, 7) Minitab for SPC, 8) JDE Enterprise 1 & Oracle, 9) BaaN, 10) EZDOC

Computer skills: 1) formatting and hard drive partitioning, 2) download HP digital camera firmware

PROFESSIONAL EXPERIENCE

Confidential, Irvine, CA

Senior Technical Writer (Consultant)

Responsibilities:

• Provided technical writing support for upgrading Medical Device R & D design control process documents (standard procedures, work instructions, project templates) to comply with FDA regulatory requirements. Design control documents addressed design input, design output, verification, validation, design transfer, regulatory, operations, risk, SDLC, reliability, and software. Assisted in creating over 160 documents, check for accuracy, grammar, correct document references, formatting, confirmed alignment of governing standard procedures with project template documents. Provided expertise to maintain consistent appearance and formatting of documents.
• Created large document map showing inter-dependencies for over 200 SOP’s, WI’s, forms, and project templates for R & D design control process.
• Deployed in Customer Quality Department to provide support for creating process documentation to address gaps identified by FDA regulatory compliance audits. Created Change Orders through EZDOC to revise existing documentation related to new Customer Quality department.

Confidential, San Diego, CA

Change Order Planner/Writer Cost Analyst (Contractor)

Responsibilities:

• Provided cost models which reflected engineering changes and BOM structure for industrial laser systems.
• Scheduled change order approval throughout workflow approval process in Agile.

Confidential, San Diego, CA

Senior Technical Writer (Contractor)

Responsibilities:

• Created and edited work instructions and process flow diagrams used for DNA consumables manufacturing processes. Originated CO’s in Agile for document release to production. Collaborated with EH&S to design hazardous chemical communication posters with universal pictograms to depict physical and health hazards for over 100 chemicals.

Confidential, Carlsbad, CA

Technical Writer (Contractor)

Responsibilities:

• Reformatted hundreds of CLIA lab documentation (work instructions, forms, SOP’s, protocols) into new documents using over a dozen template types. Reformatted documents were managed using EtQ software platform for change control.
• Co-developed novel Excel spreadsheet with embedded logic to determine testing of worksheets used in laboratory calculations based on levels of risk (safety, regulatory, process). Wrote validation protocol for risk assessment spreadsheet.

Confidential, San Diego, CA

Senior Technical Writer (Contractor)

Responsibilities:

• Converted several hundred complex and proprietary genomics analysis and sequencing reagent formulation batch records from Excel to Word format using approved batch record template with embedded spreadsheet. Resulted in elimination of duplicate batch records, correcting erroneous batch volume calculations, and batch records with consistent appearance and formatting.
• Developed technical expertise using Sharepoint as a repository for batch records ready for review and tracked progress of batch records through the approval process. Resulted in streamlined and improved batch record review process.
• Created “procedural blocks” which defined formulation processes for over 350 reagents. Resulted in 15 common sequences for reagent groups and enabled Operational Qualification deadline for Camstar Manufacturing Execution System to be met.
• Batch records deployed globally (UK and Singapore) and passed FDA audit with no errors.

Confidential, San Diego, CA

Director of Operations

Responsibilities:

• Reviewed and selected business location, negotiated lease terms, designed and implemented facility upgrades, and provided leadership in overall operations.
• Formulated pay plans for engineering staff, provided market and salary data for engineering staff, and managed payroll system for employees.
• Responsible for budget line items for process equipment. Managed million dollar budget.
• Developed multi-year business plan with owner to attract and obtain angel and venture capital funding of three million dollars. Identified funding sources for the company from personal contacts and arranged for numerous meetings between the owner and funding providers.
• Provided technical expertise to mechanical and electrical engineers to identify and resolve design issues with hydraulics, control systems, pumps, and valves. Created and managed schedule via MS Project, identified critical path, and kept prototype project on schedule and within budget constraints.
• Identified and qualified three local manufacturers to build, integrate, and test electro-mechanical sub-systems.

Confidential, San Diego, CA

Software Test Engineer (Contractor)

Responsibilities:

• Designed and conducted tests to evaluate functionality of HP printers (Laserjets, Officejets, Deskjets) and competitor products attached to HP USB wireless and Ethernet printer adapters. Reported test results to marketing managers, product engineers, and program managers for eighty printer models.
• Developed technical skills in partitioning computer drives, loading operating systems, ghosting of partition images, and recovering laptops from fatal “bluescreen” conditions.
• Tested new HP/Yahoo Toolbar over ten different laptops using Microsoft XP and Vista operating systems. Reported defects onto HP software defect tracking system.

Confidential, San Diego, CA

Process Engineer

Responsibilities:

• Increased SpectroChip micro array process yield from 85% to 95% by analyzing process data and organizing process defects using Pareto chart. Identified top three problems, made process changes, and upgraded equipment to eliminate defects. Resulted in $300,000 in savings by reducing scrap.
• Maintained and repaired clean room (Class 10,000) process equipment consisting of Cartesian Nano dispensers, low humidity nitrogen gas desiccators chambers, machine vision inspection systems, and product pouch heat sealing equipment. Chip processing was maintained while repairing equipment, deploying new equipment, and making process changes.
• Created change orders (CO’s) for existing and new diagnostic reagent kits. Initiated changes on BaaN BOM’s, process routers, production batch records, standard operating procedures, and protocols for new products to support 30% revenue growth.
• Created Master Validation Plan for new gas silation process. Gas phase process intended to reduce chemical waste stream by 75% and improve uniformity of chemical processing of SpectroChips.
• Researched and created assembly documentation required for building complex prototype liquid handling robot at third party manufacturing facility. Set up in-house prototype assembly area, purchased tooling and material handling, and organized over 500 unique parts.
• Conducted software testing for Confidential, Consumer Accessories Business. Created engineering reference specification for digital camera docking stations to support image downloading connectivity between HP digital cameras, televisions, and computers. Downloaded experimental firmware into HP digital cameras to test functionality between existing and soon to be released cameras.
• Conducted extensive time studies for Delta Design to rebalance work load for sub-assembly and final assembly of Edge product line. Resulted in 5% increase in build rate without adding manpower. Machines were used for high speed testing of Intel chip sets.

Confidential, San Diego, CA

Senior Manufacturing Manager and Project Engineer

Responsibilities:

• Managed new product introduction process of engineering prototype non-contact dispensers scale up into production.
• Managed manufacture of drug discovery instrumentation sub systems and micro-fluidic dispensers for medium volume mass production. Micro-fluidic dispensers were powered by piezo electric cylinders. Other micro- fluidic dispenser device was 48 micro valves mounted onto manifold array, used for reagent dispensing.
• Documented assembly processes for each dispenser model, justified tooling/assembly equipment, designed floor layout for class 10,000 clean room of 1,500 sq. ft., and forecasted staff and skill sets needed to build and test devices. Trained and managed technicians and assembly personnel
• Provided annual micro-fluidic dispenser production forecasts exceeding 10,000 units to plan for warranty replacements and additional demand created by instrument installations at several customer (Pfizer, Merck, Bristol-Meyer Squibb) sites.
• Improved process yields from 50% to 90% using Pareto Charts to identify process defects and verify that the improved process reduced defects. Designed experiment to determine source of quartz capillary cracking during dispenser manufacturing process. Devised unique methodology using fine wire to detect micro fractures in inner diameter of capillary not detectable by X-Rays.
• Structured BOM for complex drug discovery instrument (Automated Plate Replication System) using Oracle MRP system. APRS created daughter plates from compound library. Created item masters and structured subassemblies for production floor kit releases. APRS contained over 600 separate part numbers. Reviewed all mechanical drawings and BOM’s to confirm drawings structure and BOM structure matched. Worked with mechanical engineers to improve assembly process by recommending design changes and eliminating obstructions to assembly.