ALI BIDGOLI

***** ****** *** • San Jose, CA ***** • Tel 408-***-**** • ac9yu9@r.postjobfree.com

Accomplished Sr. Manufacturing Engineering Manager and Project Management with a solid background in Medical Devices, Consumer Electronics, PCBA/Mainframe CEM, and Automatic Test Equipment (ATE). Natural leadership and business acumen: skilled in Design Control (R&D), CM, Project Management, TQM and Regulatory Compliance in conjunction with New Product Commercialization while ensuring best practices in capacity, budgeting and cGMP. Create reliable processes, resulting in recognition for the ability to rapidly improve productivity and profitability. An equal blend of business expert and hands-on manufacturing operations & QA Engineering leader who inspires and fosters team commitment, pride, and trust while anticipating and meeting the needs of both internal and external customers. EXPERIENCE SYNOPSIS

Creative, innovative, and forward-thinking; adept at handling complex business development challenges with thoughtful, clearly defined strategies.

Technical and project management of outsourcing strategy for FAB/PCBA and main-frame chassis manufacturing, full integration & testing, contract negotiation, out-of-box quality, SCM (Supply Chain Management) and final integration of electro-mechanical assemblies with world-class contract electronic manufacturers (CEMs), including multiple CEMs in China, Japan, Korea, India and USA.

Very high proficiency in utilizing design control tools (i.e. FEMA, DOE, Risk-Management, and SPC) and TQM/QMS (i.e. Six Sigma, LEAN, 8D/5S, PDCA/SDCA, Muda, TPM, Zero-Defects, and Kaizen).

Strong working experience with complex hardware (PCB/PCBA & Power-System), electro-mechanical mainframe, cable-harness and software (Diagnostics/Calibration/Test-Programs) design & validation testing for Mixed-Signals, VLSI, Power Management, RF, High-Voltage Instruments and Medical Instrument both in R&D and volume production environments.

Worked with the Regulatory Agencies, such as ISO Notified Bodies, CE-Agencies to ensure that design specifications for the test-equipment and final products meet all applicable environmental & regulatory standards.

Established routine generations of multiple status reports for tracking of KPIs of production first pass- yield, OEE (for capital equipment’s and test-fixtures), on-time shipments, CAPAs, CARs, labor’s efficiencies and utilization factors, in respect to company’s goals and best practices in industry.

Strong working and academic knowledge of IT Development Environment, ERP/MRP (SAP, Expandable, Epicor, ASK) developments & applications, Requirements Management Tools, CRM (Clarify), PLM

(Product Lifecycle Management), Software Development Life-Cycle (SDL) and Scrum.

Received several Awards throughout career for innovation and job performance. KEY QUALIFICATIONS / SKILLS

New Product Commercialization (NPC) • Project Management • ISO9001 • ISO13485 • 21CFR820 • ISO14971 • IPC620/610 • Agile PLM • Agile-Scrum • High Volume Manufacturing (HVM) • Internal/External Audits • ERP/MRP • TQM • Lean Manufacturing • Good Manufacturing Practice (cGMP) • Design Control • Engineering Change Management process • Supply Chain Management • Capability Maturity Model (CMM) • Risk- Management • CE • DHF • 510K PMN/PMA • EU-Directives • Process Validation • Six-Sigma • Technical Files/DMR • CAPA • NCMR • SCAR • pFMEA • DFT/DFM • DOE/Flow • Gauge R&R • 8D/5S • Kaizen • SPC PROFESSIONAL EXPERIENCE

Depict Inc., San Francisco, and CA. 11/2018 – 04/2019 Operations Manager (full-time permanent position)

Management of the entire manufacturing operations of the start-up company that is bringing digital discovery to art with the revolutionary platform designed to help browse, collect, and display museum- quality art in home.

Sparton Corp., Milpitas, CA. 11/2016 – 8/2018

Sr. Engineering, Facility, Project Manager (full-time permanent position) Technical management for every step of a product’s manufacturing and lifecycle. Total focus on my customers’ vision. My unparalleled expertise and capabilities make Milpitas Sparton a premier partner for the contract design and manufacture of the low-to-medium volume highly complex PCBA and electromechanical devices.

Managed 10 engineers, 3 supervisors and over 45 technicians/assemblers along with budgeting and maintenance of over $30M capital equipment(s) aimed at state of the art PCBA assemblies and Box- building in addition to quick turn NPI, as well as, managing the entire facility of multiple sites.

Leaded projects for OEM’s from a wide range of industries including military/aerospace, medical and industrial.

Conducted routinely DFM/DFT & Internal Audits, Risk Management (ISO14971), DFMEA for new products and implementing Validation Processes (including IQ/PQ/OQ/DQ and SOP, CPI), Trace-Matrix, CAPA (using Six Sigma and TQM methodologies), Change Control and NCMR. Fluidigm Corp., San Francisco, CA. 5/2015 – 9/2016 (1.5-year full-time permanent position) Sr. Quality Assurance Engineering Manager

Embedded with the development teams where I manage product transfer to manufacturing, review QA, RA and QC processes for new and legacy products, coordinate process validation efforts, and maintain design history and technical files.

Managing QA Engineering and RA for Life Science Instruments.

Liaise with multiple product development groups throughout the product-realization process to product-launch (i.e. Instrument, Software, IFC-Interface-Fluidic-Circuit and Reagent Transition from R&D to manufacturing).

Managing approval of medical suppliers for key components, raw material, test-equipment, and services, in terms of regulatory compliance per ISO13485, 21CFR820, CE, IPC-Standards and UL/TUV/CSA requirements.

Established and implemented processes for WEEE, RoHS, READ, ESD, PPE/Gowning (BSL-2) and Products’ End-of-Life.

NPI Solutions Inc., San Jose, CA. 2014 – 2015 (9-month direct consulting job completed successfully) Manufacturing and Production Operations Manager

Management of manufacturing and production operations (hands-on) for electro-mechanical main-frame and complex cable harness assemblies along with the creation of systems to integrate global operations, supply chain management and service.

Established optimum resource & equipment utilization, capacity efficiency, and process improvement, resulting in “achievement to targeted in the reduction of backlog from 25% to 4%” in three months.

Implemented the quality system, lean-manufacturing for high technology cable harness assemblies, mechanical main-frame, electro-mechanical chassis in compliance with ISO9008/ISO13485 regulatory requirements for HVM (High-Volume-Manufacturing) along with Full Documentation, DOE, ECO, PCO, NCMR and customer returned via revised RMA process, resulted in 15% overall cost reduction. Apical Instruments, Mountain View, CA. 2013 – 2014 (11-month contract job successfully completed) Sr. Manufacturing Engineering Manager

Managed manufacturing engineering of new products R/D and production lines in support of key medical suppliers for offering a wide range of Medical Device Controllers. KEY HIGHLIGHTS

Design and author of assembly & test procedures, component selections, design documentation for system/PCA (i.e. schematics, BOM, assembly drawing) and mechanical components (i.e. PS, mechanical-chassis, OEM-parts, fabrications, cable harness).

Work within a Lean Six-Sigma/DFSS framework to periodically contribute to business/department- centric process improvement initiatives (emphasis on cycle-time/cost-reduction, design for robustness/reliability and removal of non-value-added steps)

Technical manufacturing interface with CM for design and release of PCBA, mechanical/electro- mechanical components, including PCBA, cable harness, injection molding, material procurements and quality system (i.e. First Pass Yield, Out of Box Quality, CAR) Aehr Test Systems, Fremont, CA. 2012 – 2013 (9-month direct consulting job successfully completed) Senior Lean Manufacturing Operations and Quality Manager Offered an array of strategic and operational solutions to raise the performance of manufacturing, IT and customer support groups along with acting as senior advisor to executive management for overall company’s cost reduction initiatives and corporate quality infrastructures. KEY HIGHLIGHTS

Enabled manufacturability, growth, profitability and competitive advantages for series of new Automatic Burn-in Test Systems (ABTS) beyond targeted goal within few months.

Provided implementation-focused, high-impact solutions to a variety of company’s internal processes – Including qualification of new ERP Database (Expandable) to replace the old MRP system (Man- man/ASK) within six weeks.

Reduced defective PCBA field returns by the factor of 20 percent within six months and established new MRB methodologies for ECO, field installation, and customer acceptance criteria. Third Millennium Test Solutions, San Jose, CA. 2011 – 2013 (2-year part-time as consultant) Third Millennium Test Solutions, San Jose, CA. 2/2002 – 11/2010 (10-year full-time permanent position) Manufacturing and Engineering Manager

Building on previous operations management expertise with automatic test equipment (ATE) manufacturers, recruited to establish and direct the Mixed-Signals ATE component-manufacturing initiatives of this start-up company.

KEY HIGHLIGHTS

Collaborate with research & scientific community membership in vetting ‘next-gen” concepts and technology enablers targeting future products and innovations.

Established the cross departmental NPI team to manage product introductions, improving the

“achievement to targeted release date” from 50% to 80% in only six months.

Realized a 25% reduction in manufacturing costs by successfully transitioning the in-house manufacturing of ATE instruments (PCBA), servers, cables and components to contract manufacturing.

Technical management of manufacturing/production of Mixed-Signal ATE(s) for testing technically complex medical devices and capital equipment acquisitions (up to 20 million per year), in support of medical device manufacturers (i.e. Guidant, Siemens, Micro-Semi, Maxim, Supertex), as used for Implantable Pacemaker, Automated & Custom Medical Test-Equipments/Modules in compliance with regulatory departments and standards (ISO13485, CE, ROHS/WEEE, CSA, TUV, OSHA, EU-Directives). EDUCATION & PROFESSIONAL DEVELOPMENT

M.S., Electrical Engineering, California State University, Northridge

B.S., Electrical Engineering, California State University, Northridge

ISO13485 – Medical Device Certification from Fluidigm Corp., San Francisco, CA.

Six Sigma (Black Belt) – Certification from Teradyne Corp., Aqura Hills, CA.

TQM – Total Quality Management

QMS/Kaizen – Certification from Sparton Corp, Milpitas, CA.

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