Detail-driven Manufacturing & Test Engineer eager to contribute extensive troubleshooting,

technical, and leadership talents toward supporting a dynamic organization in optimizing

bottom-line performance.

 

 

• Significant background in ISO-certified manufacturing spanning medical devices, computer hard drives and semiconductors.
• Equally proficient in electrical manufacturing, test engineering and supervising production.
• Outstanding talents in designing custom fixtures, performing in-depth testing and troubleshooting, facilitating continuous improvement, and overseeing manufacturing set-up and transfer of new products from R&D to Manufacturing.

         Highly skilled in utilizing state-of-the-art test equipment and rapidly resolving issues.

         Versatile, resourceful and committed to a zero-defect work approach.

         Able to plan, develop and execute procedures, processes, and methodologies to optimize product performance, quality, manufacturability, durability, and reliability.

         Able to precisely define goals, uncover challenges, propose modifications, and drive solution implementation to achieve measurable and immediate process improvements in production environments; excel in FMEA (failure modes and effects analysis)

         Proficient in analyzing, designing and recommending strategic solutions that boost productivity, reduce downtime, enhance customer satisfaction, and lower costs.

         Proven expertise in equipment validation through IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification).

 

 

Solta Medical Inc. (formerly Thermage Inc.), Hayward, CA, 2003 to Present

Sr. Manufacturing and Test Engineer

• Strategically partner with R&D Design Engineer and Unit Manager in coordinating release of new products, exhibiting proficiency in designing new test fixture, defining test method, and authoring work and test instructions.
• Conduct process FMEA and prepare Master Qualification Plan to achieve IQ/OQ/PQ for new tools, fixtures and equipment.
• Create engineering report to explore potential issues in manufacturing and recommend changes and design improvements through Engineering Change Order (ECO).
• Audit, train, advise and effectively support vendors in building quality products to meet or exceed company expectations and requirements.
• Teamed with Director of Manufacturing to facilitate continuous process improvements spanning production areas such as utilization, dependability, throughput, yield and efficiency.
• Reliably ensure consistent adherence to GMP and ISO-13485 for medical devices.
• Demonstrate strong forecasting skills in performing capacity and resource planning encompassing space requirements, workflow, and design layout of equipment and workspace.
• Train and coach technicians in testing and troubleshooting analog and digital boards down to component level.
• Assist service department via failure analysis down to component level of RF generators and accessories returned for service.

 

Continued

 

 

Professional Experience continued Yyyyyy x. yyyyyy Page 2 of 2

 

Smith + Nephew (formerly ORATEC Interventions), Menlo Park, CA, 1999 to 2003

Electrical Manufacturing Engineer

• Designed custom test fixtures to screen for unexpected failures and optimize product reliability.
• Contributed sharp analytical thinking abilities toward exploring and uncovering methods to reduce costs and streamline processes.
• Collaboratively transferred new products from R&D to production by documenting manufacturing and test instructions.
• Communicated with vendors to accurately determine product and/or component specifications, arrange for purchase of parts, and evaluate products according to specifications and stringent quality standards.
• Trained, mentored and supervised technicians in testing RF, CPU, I/O and Temperature boards down to component level.
• Scrutinized and determined root causes of failures in refurbished RF generators from the field.
• Determined optimum repair or upgrade strategy for returned RF generators and expedited corrective action to prevent failures from recurring.

 

Production Supervisor

• Spearheaded daily production operations inclusive of formulating production plans, coordinating department activities in alignment with schedules, acquiring production tools and equipment, and driving compliance with CGMP (Current Good Manufacturing Practice) requirements.
• Examined, analyzed and implemented ECOs affecting product or manufacturing process.
• Applied excellent management capabilities toward interviewing, hiring and training employees, conducting regular performance appraisals, and directly supervising technicians and assemblers.
• Efficiently managed, analyzed, calculated and reported on full spectrum of production areas such as utilization, yield, dependability, throughput, and efficiency.
• Documented and maintained accurate and up-to-date training records for all production personnel.

 

Prior Background:

 

PC & Network Support Technician

Etak Corporation, Menlo Park, CA, 1999

 

Process Development & Equipment Maintenance Technician

Hoya Corporation USA, San Jose, CA, 1993 to 1998

 

 

AS Degree in Electro-Mechanical Integrated Technology, Foothill College, 2000

• Dean s List, four semesters (GPA 4.0)

 

AS Degree in Electrical Engineering, Evergreen Valley College, 1998

 

 

Certified in Statistical Process Control (SPC)

 

Certified in Basic LabVIEW 0000 xxxxxx xxxx , xxxx , xxxxx 00000 and ISO 9001:2000 (medical devices)

 

 

DOS, Micro-Monitor, Windows, Pro/Engineer, AutoCAD, Word, Excel, PowerPoint, Protel98 and Protel99