Engineer Injection Molding

SUMMARY

Results-oriented Individual with “hands-on” diverse technical experience in all facets of medical device and pharmaceutical manufacturing. Proven record of accomplishments in automation of manufacturing processes and equipment design to increase capacity and profitability. Strong analytical problem solving and executing quick solutions. Understanding of clinical requirements and translation of them to product design. Skilled in engineering practices to verify and validate (V&V) new products, equipment and facilities to attain FDA compliance.

Excellent organizational planning and implementation skills. Excellent team player and customer goal oriented individual.

PROFESSIONAL EXPERIENCE

LIFE SCIENCE OUTSOURSING, Inc., Brea, CA 2009-2010

Medical Device Contract Manufacturer

Providing turnkey manufacturing, testing, validation, sterilization and distribution services.

Sr. Manufacturing Engineer

Responsible for:

• Initiation and completion of a Project.

• Reviewing all engineering drawings.

• Reviewing document change request.

• Issuing BOM and Routers.

• Customer liaison and progress report.

• Interdepartmental project update report.

• Manufacturing production line setup.

• Identifying manufacturing /assembly tooling.

• Catheter and other medical devise Packaging Design

I-FLOW CORPORATION, Irvine, CA 2008-2009

Post surgery pain treatment management

Sr. R&D Engineer

Responsible for:

• Improving elastomeric infusion pumps for consistence drug delivery over time.

• Material management and study of physical behavior of elastomeric pumps.

• Design study of various test method to evaluate the stage of cure i.e. cross link density of the elastomeric pump component.

BIOSITE INCORPORATED, San Diego, CA 2005-2008

Diagnostic device Manufacturer

Sr. Manufacturing Engineer

Responsible for:

• Managing small group of engineering/maintenance supervisors.

• Maximizing manufacturing productivity.

• Cost reduction projects.

• Sustaining and maintaining all the plastic tooling and equipments relating to manufacturing of the device components including testing, integration, validation and qualification of equipment and processes.

• Product design and development of plastic components including prototyping of such.

• Material management study to utilize most cost effective material and improve cycle time.

• Development and presentation of a business proposal of a new plastic injection molding plant including:

O Start-up of a new manufacturing facility in San Clemente California

O Specification of injection molding facility for new molding project.

O Recommendation and acquisition of injection molding machinery and its auxiliary equipment.

O Implementation, qualification and validation of all Molds, Injection molding machinery and auxiliary equipment including all documentation.

SCIENCE APPLICATIONS INTERNATIONAL CORPORATION, San Diego, CA 2001-2005

Worldwide engineering consulting firm

Sr. Project Specialist

Responsible for:

• Implementation of drug manufacturing equipment including testing, integration, validation and qualification of equipment and processes.

• Manufacturing support by equipment design and fabrication.

• Introduction of drug delivery systems into production line.

• Transferring and scaled-up of Blow-Fill processing equipment to production.

• Review manufacturing plant layout for potential cross contamination.

• Transferring equipment to new production site and validation of complete production process and equipment.

• Review and recommendation of strategies and material selection in compliance with cGMP and U.S. FDA regulations.

B. BRAUN MEDICAL, AG, Irvine, CA 1993-2001

Pharmaceutical, IV solution manufacturer

Project Engineer

Responsible for:

• Providing engineering support to various manufacturing Business units.

• Design and fabrication of prototype equipment and fixtures.

• Process improvement studies.

• Automation of costly and labor intensive product lines.

Among other activities are:

• Preparation and presentation of project package analysis to senior management including project description, estimation, justification, capital requisition, scheduling, design, design review, implementation plan, start-up, troubleshooting plan, spare part list, maintenance schedule and execution of validation and documentation.

• Re-engineering of low yield container closure, improving design to eliminate micro-bubble/ultra-sonic rejections, improving yield by 480%.

• Design and fabrication of a quality sensitive leak detection machine, developing new in-line leak detector for IV soft bag products increasing leak test through put to 100%.

• Elimination of labor-intensive silicone lubricating process, qualifying new silicone impregnated injection-molded closure, saving annually more than $200,000.

• Procurement and installation of an automated plastic container rinsing machine.

• Capacity expansion of filling line by installation/qualification of duplicated machinery.

Other Professional experiences:

American Zettler, Aliso Viejo, CA

Manufacturer of miniature electro mechanical relays.

Sr. Engineer

Responsible for:

• New product design and manufacturing support.

• Fabricating and introducing new tooling to produce new product.

• Conversion of the manually produced documentation to electronic filing system and comply with FDA guide lines and regulation.

Iolab, Johnson & Johnson, Claremont, CA

Manufacturer of Intra Ocular Lens

Staff Engineer

Responsible for:

• Manufacturing process improvement.

• Product handling improvement.

• Fixture and equipment design.

• IOL Product packaging design.

ACADEMIC BACKGROUND / CERTIFICATIONS

M.S., Mechanical Engineering, Berlin, Germany

B.S., Plastic Technology, Vienna, Austria

Proficient in SolidWorks

PROFESSIONAL MEMBERSHIPS

Member, Society of Manufacturing Engineers

Member, Society of Plastics Engineers

Member, International Society for Pharmaceutical Engineering (ISPE)

Project Management Institute (PMI)

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