Work EXPERIENCE

2013-current : Director, Engineering Programs

Cepheid, Inc.            www.cepheid.com

Overall:

1. •Director and lead across Cepheid for all of Consumables Engineering, including R&D and Manufacturing Engineering
   

2. •Managing 30+ team members across 5 groups covering 2 sites (Sunnyvale & Lodi) with diverse cross-functional backgrounds including Biomedical Engineers, Chemical Engineers, Mechanical Engineers, Biologists, Mold/Die Makers, Process Engineers, System Integration Engineers, Automation Engineers, and technicians
   

3. •Significant cross-functional responsibilities including interfacing with Manufacturing, Regulatory, Quality, Supply Chain,
   Bio R&D, Facilities, and Planning, among others, to ensure all requirements are gathered and incorporated into each project
   

4. •Responsibilities have included equipment/infrastructure updates to the consumables labs as well as to Cepheid’s molding/tooling facility, overall project schedule management, department budgets across several cost centers, recruitment/hiring/team building, and deliverables tracking (including regular updates to the Senior Executive team)
   

5. •Have driven the teams to develop, learn, and grow including sponsoring SolidWorks trainings, onsite Minitab trainings, PMP courses, leadership courses, book clubs, and volunteer events among others
   

6. •Have coached individual Consumables R&D team members and managers to develop the group into a high-functioning, productive, and innovative product development and validation team
   
   

R&D Engineering:

1. •Established a new Consumables R&D group (2014) to accelerate a strategic project to enable highly-multiplexed PCR in Cepheid’s GeneXpert systems
   

2. •Led the Consumables R&D group (incl. individual contributor duties) to perform all research, development, and testing of specific microfluidic parts, establish feasibility for injection molding of these parts as a new consumable cartridge component, achieve robust PCR functionality using integrated chemistries, and transfer of the new platform to Cepheid Bio R&D groups for oncology assay development
   

3. •Established a new Injection-Molding and Tooling R&D group (2015) to provide prototyping services across all of Cepheid including projects to resolve issues within Cepheid plastics manufacturing, molding of prototype consumables components followed by production tool design and build, and molding of prototype instrument components incl. gears and lenses
   
   

Manufacturing Engineering:

1. •Responsibilities and oversight were significantly increased in 2015 with the addition of Consumables Manufacturing Engineering groups including engineers and technicians responsible for design-for-manufacturing (DFM) improvement projects as well as production qualification/validation of new injection-molding tools and automation lines for capacity/growth
   

2. •Mfg. Eng. responsibilities included ownership of cartridge consumables part designs, and ownership of validation (OPQ) activities on tools associated with the cartridge consumables parts including the injection-molding presses/tools and automation lines for subassembly and finished IVD goods
   

3. •Drove major capacity initiatives to improve supply of overmolded cartridge body parts by working with Supply Chain, external vendors, and Manufacturing to initiate & accelerate additional tool builds/qualifications, initiate scrap reduction projects, and  implement swing tool strategies
   

4. •In 2016 alone, Mfg. Eng. teams successfully completed validation/qualification of 15+ new molding tools, re-qualification (due to site transfer or repair/refurbishment) of 20+ molding tools, and validation of 3 new manufacturing lines on schedule to restore the cartridge body supply chain and improve capacity to maintain Cepheid’s double-digit percentage sales growth
   

5. •Drove major effort within Mfg. Eng. teams to rebuild, clean-up, and harmonize all component CAD models, 2D drawings, visual aid documents, and validation/qualification protocols (OQ/PQ)
   

6. •Initiated metrology program to develop, document, and validate consumables metrology measurement methods and harmonized methods across multiple external molding vendors leading to expedited qualification and injection-mold tool bring-up timelines
   

Cepheid-Northrop-USPS BDS Program:

1. •Cepheid’s technical program lead for the Biohazard Detection System (BDS), a national security partnership between Cepheid, United States Postal Service (USPS), and Northrop-Grumman (NG) to screen mail for Anthrax w/molecular testing
   

2. •Leading all of Cepheid’s technical, business, and customer aspects of the BDS program, including supply of consumable test cartridges to USPS and service/support of system hardware for NG
   

3. •Duties have included forecasting, supply chain management, manufacturing management, shipping/transportation logistics, technical change control, contract negotiations, resolution of field issues, database management & monitoring, and regular partner meetings with both USPS & NG incl. ISO audits
   

4. •Successfully addressed several business continuity (BCP) concerns with the BDS program while maintaining a $20 mil+ yearly revenue stream in a time of rapid change with USPS and mail demand
   

5. •Successfully drove negotiation of new multi-year program contracts with USPS & NG as well as external suppliers to Cepheid to continue support of the program through 2020 while concurrently addressing legacy program issues
   

2011-2013 : Product Development Program/Project Manager

Cepheid, Inc.            www.cepheid.com

1. Worked as a project manager for Cepheid’s Research and Development groups, including Engineering, Systems Integration, Software, and BioAssay projects
   

2. Acted as the sole Systems/Software program/project manager, including projects for developing GeneXpert systems, GeneXpert software, and new consumables/cartridges
   

3. Duties included core team formation, schedule development and tracking, conflict management, resource management, risk management, and adherence to ISO 13485 from concept to product launch and post-market surveillance
   

4. Managed large, cross-functional, international core teams while significantly contributing to design, verification/validation, manufacturing, regulatory, and marketing initiatives, among others
   

5. Additional duties included strategic program planning at the Executive level and product lifecycle improvements
   

6. Successfully launched over 10+ IVD products in 2 years, including systems projects (Infinity-80 and Infinity-48s instruments, Xpert Calibration), software products (Xpertise and Dx product software), and assays (Xpert CT/NG, Xpert Flu)
   

2010-2011 : Microfluidic Immunoassay research and development

Biomedical Diagnostics Institute - Dr. Jens Ducrée            www.bdi.ie

1. Worked as a post-doctoral researcher in the microfluidics group at the Biomedical Diagnostics Institute in Dublin, Ireland
   

2. Research work was focused on development of an automated, microfluidic immunoassay system in collaboration with Millipore, including integration of microfluidic sample prep, surface chemistry, fluorescence detection, and hardware systems
   

3. Other projects included a magnetics-based bioseparation platform, unique valving methods, and new surface chemistries
   

4. Also set up entirely new labs and installed new lab infrastructure, including process development and lab management
   

5. Additional tasks involved student mentoring and supervision, including the management of several M.S. and B.S. students
   

2006-2011 : continuous glucose monitoring research and development

iGlyko, Inc.

1. Worked on the development of an intravenous, fiber-optic glucose sensor for in-hospital tight glycemic control (TGC) using genetically engineered proteins, including co-founding a start-up company (iGlyko, Inc.)
   

2. General duties included setting up laboratory space and assisting in creation of research and business teams through training and recruitment
   

3. Scientific duties included management of a small team for fiber-optic system design, protein handling chemistries, hydrogel optimization, development of protocols, hardware automation, and detailed development planning
   

4. Established in vitro sensitivity & specificity proof-of-concept in whole blood
   

5. Business duties included business plan writing/presentations, searching for funding from investors (angels, investment bankers, and VCs), grant writing (SBIRs), and webmaster
   

2006-2009 : research on Microfluidic platforms for nucleic acid-Based DISEASE diagnostics

UC Irvine - Dr. Marc Madou            www.biomems.net

1. Research for doctorate degree on development of microfluidic sample lysis, PCR, and DNA microarray hybridization platforms to integrate into a sample-to-answer system as part of a multi-million dollar, international Genome Québec initiative
   

2. Developed a microfluidic system for bacterial detection that combined cell lysis with real-time PCR as part of a DARPA-sponsored initiative within the unique MF3 center
   

3. Utilized microfabrication and manufacturing skills to create disposable, low-cost, polymer microfluidic devices both in and out of cleanroom facilities
   

4. Fabricated and automated platform instrumentation, including fluorescence detection systems, feedback control systems for thermocycling, and magnetic actuation systems for sample preparation
   

5. Research work also included handling and performing relevant biological assays, such as the optimization of qPCR reactions and the handling of blood/cells
   

6. Additional duties included lab management, webmaster, and numerous grant writing efforts (NIH, NSF, and others)
   

2007, fall : RNA amplification assay development

Hologic (formerly Gen-Probe) - Dr. Norm Nelson            www.hologic.com

1. Worked in Gen-Probe’s biochemistry R&D group on RNA amplification and detection assays
   

2. Developed and optimized various forms of transcription-mediated amplification (TMA) assay for prostate cancer diagnostics
   

3. Reactions were run in a 96-well plate format using real-time molecular probes for multiplexed detection
   

4. Work included designing and carrying out experiments as well as data analysis and quantitation
   

5. Additional tasks involved instrumentation optimization such as protocol development for magnetic bead-based target-capture and automated well-plate dispensing
   

2001-2005 : research on MEMS Neural Stimulation Probes and 3D Electrodeposition

UCLA - Dr. Jack Judy

1. Worked in a microsystems (MEMS) lab on micromachined, deep-brain stimulation probes for Parkinson’s Disease research
   

2. Tasks included running tests to determine optimum electroplating conditions for micro-probe production, circuit design/construction, and packaging of external circuits for animal testing
   

3. Also worked on electroplating simulations involving 3D modeling using MATLAB, and validation of the models for accuracy against experimental, 3D plated structures
   

4. Was trained in UCLA's Nanofabrication facilities and well versed in the basic equipment and processes involving the fabrication of devices on Si wafers using oxides, nitrides, polysilicon, and metals in combination with deposition, masking, and etching
   

2004, Summer : Quantitative Microscopy Research

UCSD & The Burnham Institute - Dr. Jeff Price   

1. Worked in various imaging labs, running phase-contrast image scans of tissue micro-arrays
   

2. Was exposed to basics of phase-contrast, fluorescent, confocal, and automated microscopy
   

3. Worked on image processing algorithms, specifically Matlab-based, edge-detection software
   

4. Was exposed to basics of flow-cytometry
   

2002, Summer : biolistics Research

Lawrence Berkeley National Laboratory - Dr. Jian Jin   

1. DOE/NSF sponsored undergraduate research fellowship program (ERULF) at the Lawrence Berkeley National Lab
   

2. Research involved development of a biolistic gene gun for transfection of C. elegans roundworms
   

3. Work included design modifications, experiment design, testing, a research paper, a poster session, and hands on skills such as metal machining, soldering, and programming