Manufacturing/Project/Quality Engineer

Daniel Tam

Career Summary

GMP experience in medical devices and biopharma industry with prior electronic manufacturing test and quality engineering background. Interest areas include project management, process/equipment validation, continuous process quality and cost improvement.

Education

B.S. in Electrical Engineering, California State University, San Jose, CA

B.S. in Biochemistry, University of California, Davis, CA

Experience

Equipment Project Engineer Cushman & Wakefield, CA/Advantis Global, Inc Jun 2017 – Aug 2017

Supported a site maintenance service project at Genentech Corp in South San Francisco, CA. Coordinated the efforts to migrate paper PM procedures to mobile device based platform. Utilized Microsoft Access SQL and Excel functions to analyze site wide equipment and their maintenance plans data in SAP, and to coordinate and implement appropriate Bills of Materials (BOMs) updates and maintenance activities.

Process & Facilities Reliability Support Engr Bayer Healthcare, Berkeley, CA/Naderi Eng’rg Inc Jan 2012 – Dec 2016

Provided full-time technical support to Maintenance & Reliability Engineering Department

Identified alternative like-for-like replacements for obsolete parts and materials

Resolved ~200 constrained parts (CAPA) annually

Worked with Subject Matter Experts (SME) and quality engineers in resolving equipment issues and for change order review & approval

Updated affected BOMs and maintenance task lists

Coded VBA Excel macros in analyzing SAP data and identifying root causes for low service KPI

Coordinated supplier change notifications process evaluation and corrective activities

Forecasted and coordinated parts deliveries to meet emergency repairs and critical PM activities

Material Data/Tech Support Engr Genentech Corp, S.S.F., CA/Naderi Eng’rg Inc Jul 2006 – Nov 2011

Provided full-time technical support to MRO Store & Facilities Maintenance Tech Support Group

Field verified installed equipment parts and devices against SAP BOMs, P&ID drawings, Turn Over Package (TOP) records

Researched & identified alternative like-for-like replacements for obsolete parts and materials

Worked closely with Subject Matter Experts (SME) and quality engineers for change order review and approvals per QMS procedures

Updated affected CMMS and SAP database info & records, i.e. BOMs, maintenance plans

Tech Support Engr Alza Pharma., Mountain Vw., CA/Altran Corp Jul 2005 – Apr 2006

Provided full-time contract technical support services to maintenance and engineering staff members

Worked with technicians validating clinical process equipment

Designed, validated, and documented new maintenance tooling and procedures for servicing Alza’s custom made vacuum mixers for its Class III sub-dermal osmotic pump and drug product

Documented equipment maintenance procedures in SOP’s

Daniel Tam

Sr Manufacturing Engr Molecular Dynamics, Sunnyvale, CA Jul 2001 – Nov 2003

Supported ISO 9001 manufacturing of high throughput DNA sequencing analyzers

Supported manufacturing in investigating customer returns for root causes

Improved the yield of capillary arrays using design of experiment (DOE) & R&R studies in determining problematic root causes

Improved quality and reduced labor time by standardizing laser alignment and other manufacturing assembly procedures

Documented changes in manufacturing SOP procedures and re-trained manufacturing personnel

Sr Manufacturing/ Quality Engineer Lam Research, Fremont, CA May 1999 – Jul 2001

Supported Auto Chemical Mechanical Polisher Cleaner ISO 9001 and lean manufacturing process

Optimizing manufacturing process Takt time, tracking and reducing manufacturing defects

Implementing appropriate engineering changes (ECR/ECN) & correcting and updating BOM’s, and manufacturing SOP documents

Diagnosed and resolved problematic issues with suppliers

Coordinated the supplier related ECR and implemented corporate level material purge activities

Upheld the principle of “Made to Print” for all parts, i.e. specs were correct and parts met all specs

Reviewed and updated First Article Inspection, AQL inspection plans for incoming parts

Maintained the quality records and documentations in compliance with ISO 9001 and QMS procedures

Product Manager Itochu Technology, Santa Clara, CA Jun 1994 – Feb 1999

Responsibilities included OEM equipment technical sales projects and presentations, demonstrations and training. Led a small group of field service technicians. Worked closely with local U.S. customers and oversea OEM vendor to assure customer satisfaction throughout product life cycles.

Successfully introduced four new automated products to the U.S. market – glide and certify test systems, laser texture systems, laser optical surface defects inspection systems and cassette carrier systems

# of U.S. customers grew from one to five in three years

Increased annual sales revenue from $3M to $35M in three years

Principal Engineer Western Digital, Santa Clara, CA Jan 1993 – May 1994

Supported ISO 9001 high volume SPC production process with the goal of reaching six-sigma ideals

Tracked and monitored outliners and took immediate actions, i.e. equipment calibration check, product failure analysis, to address and resolve concerns

Conducted experiments to evaluate process variables, i.e. human impacts on product quality and yield, testing algorithms impacts on production yield and potential escapes

Test Engineer Toshiba America Info System, San Jose, CA Jan 1991 – Dec 1993

Supported new product development and scale-up manufacturing

Worked with local and overseas head and media contract manufacturing vendors (CMO) on testing SOP, gage R & R studies, equipment correlation and qualification, AQL inspection & testing criteria

Test equipment ranged from head/media component coercivity testers, magnetic disk testers, head stack certify testers and disk drives with the aids of signal generators and spectrum analyzers

Skills & Abilities

Versatile problem solving engineering skill set. Strive to promptly respond to customers’ requests

10 years of GMP & ISO science-based risk assessment and management work experience

Familiar with Excel VBA, PowerPoint, Access SQL, Java, Python, FreeCAD 3-D modeling

Contact this candidate