SUMMARY:

• Diverse experiences with aptitude in engineering, manufacturing, design, quality assurance, science, finance and environmental consulting.
• Accomplished strengths: problem resolution; technical report writing; project planning; teaching and meeting deadlines.
• Personal characteristics: high emphasis on dependability; self - motivation; capable organizational skills; proficient people skills; effective oral and written communication.

PROFESSIONAL EXPERIENCE:

Confidential, Northridge, CA

Senior Manufacturing Engineer

Responsibilities:

• R&D engineer to support DVT & Qualification testing of a Hospital Venture project. Development of a continuous glucose monitoring system (Sentrino®) for management of Type I and Type II diabetes.
• Functional verification, system analysis and risk assessment of a glucose sensor system to ensure reliable detection and prevention of hypoglycemic and hyperglycemic events in hospital patients using clinical study product approved for international release in the UK and regions of Europe, specifically Denmark, Italy and Germany. Travel required to off-site suppliers. Provide engineering support in Operations for testing, process improvement and mistake proofing of an implantable sensor for insulin patients.
• Implemented cost reduction programs with contract manufacturing organizations (CMOs) to achieve long term cost reduction goals in an FDA regulated environment. Engineering support required at supplier facilities to streamline and resolve project issues.
• Created and maintained a rigid schedule for increasing manufacturing capacity, including mistake proofing and risk assessment.

Confidential, Sylmar, CA

Senior Design Assurance Engineer

Responsibilities:

• Resolved manufacturing flow-line processing issues of implantable pace makers (pulse generator), cardiovascular leads and ICD devices.
• Performed CAPA, PIR, dFMEA/pFMEA, product risk assessments, mitigation and fault isolation .
• Wrote detailed manufacturing procedures, specifications, operating procedures, engineering tests plans, reliability reports, qualification and process validation plans & reports for US, Puerto Rico and Malaysia facilities.
• Master molds and injection mold dies to manufacture silicone components on implantable cardiovascular leads. Design/develop “soft” tooling, sustaining production fixtures, integrate an automated robotic pattern recognition vision system for progressive in-line detection of defects during the manufacturing cycle.
• R&D specification review. Approve pre-production drawings prior to manufacturing release. Performed design verification tests (DVT).
• Investigated patient field complaints & device explant studies. Evaluated product defects, functional performance evaluations and root cause analysis with R&D. Established corrective action requirements to ensure compliance and reliability. Travel to off-site and overseas locations.
• Participated in Material Review Board (MRB) and Engineering Change Board for review/approval of document changes. Contributor in off-site manufacturing issues at supplier facilities and nonconformance issues.
• ISO 9000 certification activities and GMP procedures. Support FDA audits, inquiries and observations. Wrote engineering reports with foreign contractors to release the building and facility systems at new sites in Puerto Rico & Malaysia.
• Certificate of Appreciation Award that reduced product defects and manufacturing time/costs. Certified Six Sigma Green Belt recipient for mistake proofing manufacturing issues on medical devices. Diagnostic trouble shooting techniques and implemented quality functional changes that improved product reliability. Interfaced with Regulatory, Health Care officials on various matters.
• Implemented cost reduction programs with contract manufacturing organizations (CMOs) to achieve long term cost reduction goals in an FDA regulated environment. Involved engineering support at domestic and foreign CMO facilities.
• Participated in the implementation of a project to expand on-site capacity of the Ethylene Oxide (ETO) process to sterilize implantable pacemakers and ICD devices.

Confidential, Los Angeles, CA

Senior Manufacturing Engineer

Responsibilities:

• Performed failure analysis & fault isolation on hydraulic electromechanical aviation control subsystems (servo-valves and actuators).
• Problem solved pre-production and full-scale development flight control systems deliverable to Boeing, Lockheed.
• Wrote manufacturing procedures and illustrated component assembly diagrams.
• Designed production tooling, fixtures and assembly aids.
• Defined & implemented test requirements for servo-actuator components used on flight control systems.
• Corrective Action Committee member. Implemented advanced process enhancements in production.
• Received Achievement Awards for multiple cost saving and mistake proofing concepts.

Confidential, Ventura, CA

Scientist

Responsibilities:

• Wrote engineering proposals and environmental management plans/reports.
• Participated in the design, implementation and management of a heavy metal waste water control system used to remove trace elements of selenium, mercury, lead, arsenic, and chromium from food service processing water.
• Filed environmental impact permits with the Confidential .
• Wrote Industrial Pollution Prevention Plans and Storm-Water Discharge Procedures for industrial clients.

Confidential, Valencia, CA

Senior Manufacturing Engineer

Responsibilities:

• Failure analysis on servo-actuator production discrepancies. Designed/implemented advanced process improvements for electro-mechanical systems for various projects as: (i) The MX Missile Thrust Vector Subsystem manufacturing test time reduced from 11½ to 2 hours; (ii) Confidential -64 Apache Helicopter monosphere bearing replacement time reduced from 14 to <1½ hour; (iii) B-1 Bomber rotary launch system assembly and test reduced from 5 to <2 hours.
• Achievement awards for the design, development and implementation of: (i) F/A-18 Aileron manifold poppet gauge; (ii) automated computer insulation resistance and hypot verification test equipment; (iii) automated electronic test consoles and test algorithms for the MX Missile Subsystem; (iv) implemented a new bearing replacement process on Confidential -64 Apache pylon system.
• Traveled to military facilities to trouble shoot control system malfunctions installed on various classified/restricted aircraft: B1-B bomber for rotary launcher over-shoot; F/A-18 Hornet for aileron seizure; C-17 Globe Master III transport for mono-ball alignment; Confidential -64 Apache Helicopter and MX missile program to meet compliance for Mil-Std criteria.
• Wrote procedures for chrome a metal plating processes in compliance with Confidential and Confidential requirements.

Confidential, Oxnard, CA

Senior Manufacturing Engineer

Responsibilities:

• Conduct fault isolation tests on electro-mechanical servo actuator aviation controls. Development of an optical flow grind system to improve diametrical tolerance less than fifty-millionths clearance for the sleeve & spool on hydraulic servo assemblies.
• Root cause analysis performed to resolve an F-16 servo electrical failure; scrap losses decreased 52% to <½%.
• Implemented advanced processes proposed to Confidential to recover servo coils rejected for dielectric failure; recaptured 90%.
• Eliminated corrosion defects on high pressure hydraulic jet nozzles due to contamination.
• Eliminated suspended ions in DI process water for EDM procedures.