Manufacturing Engineer

Aleksey Yeremin San Jose, California

*********@*********.***

CAREER SUMMARY

With over 20 years of experience in R&D, process engineering, and manufacturing for medical devices and aerospace, I bring a wealth of expertise to the table. My background spans the entire medical device development cycle, from concept to commercialization. Here are the key highlights:

Medical Start-Up Environments: I thrive in dynamic start-up settings, where innovation and agility are paramount. Leveraging my knowledge of electromechanical assembly and in vitro diagnostic devices, I’ve driven product excellence and breakthroughs.

Process Engineering Excellence: I have successfully designed and optimized processes, ensuring efficient production and adherence to quality standards. My familiarity with ISO standards, GMP guidelines, and FDA regulations allows me to navigate complex compliance requirements effectively.

Collaborative Approach: I excel at cross-functional collaboration, working closely with R&D teams, manufacturing units, and quality assurance departments. My ability to bridge technical and business aspects ensures seamless project execution.

WORK EXPERIENCE

SA Photonics Division of CACI Inc., Los Gatos, CA

Manufacturing Engineer 11/2022 – 03/2024

Support daily operations for the manufacturing of complex, state-of-the-art laser satellite communications systems for military, space, and commercial applications. Process development, documentation, ECOs, process training, and responsibility to maintain production yield, quality, and cost reduction.

Plan and support the build and modification of electronics systems including procurement support, assembly method/work instructions generation, tooling design support, material/process development, facilities/equipment planning, and resolution of manufacturing, quality, and reliability issues. Work with design engineers to ensure hardware productivity and develop build strategies.

Directing support personnel in the day-to-day execution of manufacturing tasks.

Left the company due to labor force reduction (layoff)

CAIRE Diagnostics, Pleasanton, CA

Operations Manager 06/2015- 10/2022

Supported daily operations for Fenom Pro® Asthma Monitor and pilot line manufacturing, working with suppliers, logistics, distributors, quality, and commercial teams.

Managed forecast input, MRP processes, inventory, logistics, manufacturing output, yield/cycle time, and facilities; created and execute annual Operating Plans.

Hired, supervised, and developed operations talent; manage North American service center direct labor and pilot line manufacturing for new products.

Rationalized sales forecasts, coordinate supply chain, oversee hardware production planning, order fulfillment, and shipping/receiving.

Established/refined business workflows, ERP system improvements, and supplier agreements; advise support services

Sr Manufacturing Engineer

Lead engineer for manufacturing Fenom Pro® and Fenom HOME® POC and self-monitored devices, including clinical trial preparation and commercial manufacturing.

Oversaw procurement, calibration tracking, and maintenance of laboratory and manufacturing equipment.

Defined product requirements and developed verification/validation procedures.

Assisted in executing characterization experiments, data collection, and analysis.

Maintained mechanical design drawings in SolidWorks and electrical designs in Altium.

Set up pilot manufacturing lines in California, Ohio, and Singapore.

Staff R&D Engineer

Procured equipment, supplies, and permits for the R&D lab.

Designed fixtures for testing and characterizing Fenom devices.

Assisted in executing characterization experiments, data collection, and analysis.

Defined calibration procedures (flow, temp, ext.) and final product testing procedures for Fenom devices.

Left the company due to labor force reduction (layoff)

Sonitus Medical, San Mateo, CA

Manufacturing Engineer 05/2012 – 01/2015

Development and product transfer of wireless bone conductive hearing aid from Systems Engineering and Product Development into manufacturing. Develop processes, set the production area layout, design fixtures, and manufacturing aids. Qualify manufacturing equipment and test instruments. Participate in Verification and Validation protocol development, testing, and reporting. Create and maintain assembly documentation, such as manufacturing procedures, records, BOMs, drawings, etc. Analyze failures and product returns and initiate corrective action and preventive actions (CAPA). Conduct studies to determine cycle times, throughput rates, and manpower requirements.

The company went out of business

Nanostim, Inc., Sunnyvale, CA

Manufacturing Engineer (Consultant) 08/2011 – 01/2012

Assist in the design of the production area layout to improve cycle time and ESD control, and development of processes and fixtures for the leadless pacemaker project.

Short term contract

EarLens Corp, Redwood City, CA

R&D Engineer 08/2009 – 05/2012

Design and perform assigned experiments on a photonic hearing aid project; LED and laser beam calibration, Laser Doppler Vibrometer (LDV) testing, and photovoltaic (PV) cell characterization. Write technical reports. Assemble and test prototypes. Recommend new methods, procedures, and techniques for solving specific project problems. Develop tooling, fixtures, and processes. Create and maintain assembly and test procedures.

Left the company due to labor force reduction (layoff)

Apieron Biosystems, Menlo Park, CA

Process Engineer 01/2006 – 06/2009

Primary engineer supporting manufacturing of the respiratory trace NO gas analyzer. Assist in establishing product requirements, conducted and oversaw product testing during Verification and Validation (V&V), material selection, risk/failure mode assessment, performance, and safety testing. Work closely with design engineering to improve product design for manufacturability. Implement new processes, train operators, troubleshoot process issues, develop manufacturing procedures, and conduct process characterization studies and DOE's (Design of Experiments). Vendor management. Develop and validate test methodology. Assist with post-production GMP compliance.

The company went out of business

dpiX, Inc., Palo Alto, CA

Test Equipment Maintenance Engineer 07/2004 - 01/2006

Perform corrective and preventive maintenance on test equipment used in the manufacturing of high-resolution large-area amorphous (a-Si) sensor arrays used in medical, security, and non-destructive testing industries. Diagnostic troubleshooting and repair of test tools such as Full Contact Testers and Laser Repair Stations consisting of mechanical, electrical, optical, hydraulic, and pneumatic systems in a cleanroom environment. Procurement, inventory control, and database maintenance of spare parts.

The company was relocated to Colorado.

HealtheTech, Inc., Los Gatos, CA

R&D Engineer 04/2001 - 02/2004

Perform various R&D engineering activities such as design, test, modification, fabrication, and assembly of medical electro-mechanical systems and experimental design circuitry of a respiratory O2 gas analyzer. Perform schematic entry and PCB layout. Using created schematics, diagrams and sketches performed assembly, test, and troubleshooting of early prototypes. Conduct tests to collect design data for product development. Design, construction, and validation of test equipment. Troubleshoot, maintain and support existing automated and manual production test fixtures. Support transition and validation of manufacturing from R&D to contract manufacture (California and Colorado).

The company was relocated to Colorado.

Applied Materials/Refurbishing Division, (Santa Clara, CA)

Engineering Technician 10/2000 – 04/2001

Integration, testing, calibration, and repair of complex semiconductor fabrication equipment, such as Centura HDP-CVD, consisting of electronic, mechanical, vacuum, fluid flow, and pneumatic sub-systems

Left the company due to labor force reduction (layoff)

Crane Corporation/Aerospace Division, (Lynnwood, WA)

Environmental Test Technician 02/1999 – 10/2000

Reliability and structural integrity testing of proximity and pressure sensing components fabricated for the aerospace industry; thermal, vibration, gravity, extreme voltage, and resistive load cycle testing.

Maintain test documentation in compliance with Federal Aviation Administration (FAA) regulations. ESD safety officer.

Relocated to California

ATL/Philips Medical Systems and Solectron, Inc (Bothell, WA and Everett, WA)

Board Test and Repair Technician 12/1997 – 01/1999

In-circuit test, functional test, troubleshooting, and repair of Pin-through-hole and SMT printed circuit assemblies (PCAs) used in ultrasound and other medical equipment.

Left for a better job opportunity

Design Bureau of the Moscow Radio Plant of Almaz-Antey concern, (Moscow, Russia)

Design Engineer 09/1987 - 08/1993

Bureau is the parent developer of the Russian air defense missile systems.

Worked for this Bureau through the University. Began career as a draftsman with promotions to design draftsman, electronics systems analyst, and then to design engineer of the anti-aircraft rocket systems.

Left for a better job opportunity

EDUCATION

The Moscow State Technical University, Moscow, Russia

Master's Degree in Electrical Engineering with an emphasis on the design and manufacturing of electronic devices.

ADDITIONAL SKILLS

-Product Development and Manufacturing:

oProficient in the product design cycle from concept to market release.

oHands-on experience transferring Class II and III medical devices from R&D to production.

oSkilled in process engineering of custom medical devices, lean manufacturing, and continuous improvement.

oExpertise in setting and validating manufacturing processes and equipment globally.

-Regulatory and Quality Assurance:

oSolid understanding of FDA Quality System Regulation (QSR), GMP Guidelines, Medical Device Directive, ISO 13485, ISO 9001, and international regulatory requirements.

oFamiliar with IPC-610 standards.

oExperienced in IQ/PQ/OQ protocols and proficient in testing and documentation.

-Statistical Analysis and Reporting:

oProficient in statistical analysis techniques including F-test, t-test, ANOVA, and generating trend reports.

-Software and Tools:

oSolidWorks (2018 Essentials), Altium (2019 Schematic and PCB layout), CAMtastic (Protel).

oMATLAB, LabVIEW, JMP, Microsoft Office Suite (Word, Excel, Access, PowerPoint, Visio), DXP, Omnify, Oracle’s JD Edwards, Arena.

-Additional Expertise:

oInjection Molding (2019 FATHOM Services essentials training), materials & adhesive research, DFA, cost reduction, and lean processes.

oCreation and execution of Verification and Validation protocols, new product rollout, root cause analysis, and productivity improvements.

oOfficer of Internal Audit Quality Systems, experience maintaining a class 7 cleanroom.

oInstallation and validation of 3D scanners and printers.

-Management Experience:

oOperations Manager overseeing assembly, technicians, and operation specialists (up to 10 personnel).

oProject and vendor management, supplier evaluation, and audit.

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