Rachmat Shaleh

Rachmat Shaleh Email and Phone Number

Mechanical Engineer | Process Engineer | Design Engineer | Manufacturing Engineer | Quality Engineer @ Virtue Diagnostics Indonesia
Rachmat Shaleh's Location
West Java, Indonesia, Indonesia
About Rachmat Shaleh

At Virtue Diagnostics Indonesia, my proven track record in process R&D and manufacturing processes is the cornerstone of my approach in leading critical projects. With a focus on IVD instrument excellence, I've successfully overseen the design and setup of a production line targeting a capacity of over 500 units annually. My role involves meticulous documentation, spearheading new product design transfers, and ensuring project timelines are met with precision.Leadership is a key component of my professional ethos, where I guide teams toward continuous improvement and troubleshoot production issues to uphold product quality. My expertise in equipment preparation enhances productivity, and as a Senior Process Engineer, I am committed to fostering innovation and efficiency in every aspect of our manufacturing operations.

Rachmat Shaleh's Current Company Details
Virtue Diagnostics Indonesia

Virtue Diagnostics Indonesia

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Mechanical Engineer | Process Engineer | Design Engineer | Manufacturing Engineer | Quality Engineer
Rachmat Shaleh Work Experience Details
  • Virtue Diagnostics Indonesia
    Sr. Process Engineer
    Virtue Diagnostics Indonesia Aug 2024 - Present
    Jababeka Industrial Estate Vii, North Cikarang
    Sr. Process Engineer of IVD Instruments with responsibility as follows :1. IVD instruments process-related documentation, include SOP, WI and validation files. 2. As operation representative to attend NPI project, also work as R&D to complete new product design transfer.3. Lead manufacturing transfer project, track and monitor progress, to ensure project on schedule.4. Design & Setup Instrument IVD Line Production with target capacity >500 units/year.5. Lead Subordinates as key of product quality to do troubleshoot all production issues and drive continuous improvement in production (Assembly, Debugging, QC/testing, Packing). 6. Equipment, Jig/Fixture & Tools preparation to support increment of productivity.7. Lead investigation, root cause analysis and risk assessment, track the effectiveness of countermeasures. 8. Support product registration activity with other department to ensure product registration and type testing on track. 9. Make part design / development and evaluation of mechanical/structural of Instruments with consider to Quality, Cost, Productability, Serviceability, Safety.10. Lead Testing/evaluation Product performance and safety align as User Requirement Specification according to IEC & SNI standard.11. Work with R&D to write DDF, MDF and registration technical files for new products.12. Work close liase accross Department to support project smoothly of Domestic Medical Devices Product (AKD) and raise up value as much as of Local Content (TKDN) for each Instrument13. Continuous Improvement & 5S support activity in Instrument Manufacturing
  • Virtue Diagnostics Indonesia
    Process Engineer
    Virtue Diagnostics Indonesia Nov 2023 - Aug 2024
    Jababeka Industrial Estate Vii, North Cikarang
    Process Engineer of IVD Instrument such as Hematology Analyzer & Chemiluminescence Immunoassay Analyzer, with responsibility as follows :1. IVD instruments process-related documentation, include SOP, WI and validation files. 2. As operation representative to attend NPI project, work with R&D department to complete new product design transfer.3. Attend manufacturing transfer project, track and monitor progress, to ensure project on schedule.4. Design & Setup Instrument IVD Line Production with target capacity >500 units/year.5. Solve the key quality and production issues and drive continuous improvement in production (Assembly, Debugging, QC/Testing & Packing). 6. Equipment, Jig/Fixture & Tools preparation to support increment of productivity.7. Lead investigation, root cause analysis and risk assessment, track the effectiveness of countermeasures. 8. Support product registration activity with other department to ensure product registration and type testing on track. 9. Do part design of mechanical/structural development of Instruments with Focused on Quality, Cost, Productability, Serviceability, Safety.10. Work with R&D to write DDF, MDF and registration technical files for new products.11. Work close liase accross Department to support project smoothly of Domestic Medical Devices Product (AKD) and raise up value as much as of Local Content (TKDN) for each Instrument12. Continuous Improvement & 5S support activity in Instrument Manufacturing
  • Pt Phc Indonesia
    Senior Leader Of Mechanical Design Engineer
    Pt Phc Indonesia Sep 2022 - Oct 2023
    Mm2100 Industrial Town Cikarang, Bekasi
    PT. PHC Indonesia (PHCI) - Formerly known as Panasonic Healthcare IndonesiaAct as a Design Team Leader in Mechanical/Structure Section for New Development of Biomedical Product, such as Pharmaceutical Refrigerator (MPR), and Blood Refrigerator (MBR) with low-mid-large volume.1. Lead Team with 5 subordinates in new project of design product & New Model Development Stage : Working Sample (WS), Design Review (DR), Part/Product Design Review (PDR), Engineering Sample (ES), Acceptance Quality (AQ)- Take Over of Pilot Run (PR)2. Provide Bill of Material (BoM) and Manufacturing specification standardize3. Proceed and control release of New and current parts-products for Specification Change Notification (SCN) / Technical Change Notification (TCN) consider to Quality, Cost, Delivery, Productivity, Serviceability / Safety (QCDPS check)4. Mechanical/structural of design evaluation parts-product accordance to global regulation in medical devices/ JIS, ISO, IEC standard :(ISO 13485, ISO 14971, IEC 61010-1, etc)5. Do benchmark of many competitors for further reference to make competenece product in global trend6. Make efficient and optimize of design with focus on Quality, Cost, Reliability, Usability Processability, Serviceablity, Safety7. Design Prototyping, Testing, Verification and validation8. Parts & Product Evaluation according to Mechanical sectoral standard9. Jig and fixture design confirmation 10. Support Part-product of current design/ MP products to improve of Residual occurence about quality issue11. Support Value Engineering (VE) activity
  • Pt Phc Indonesia
    Senior Leader Of Factory Engineering
    Pt Phc Indonesia Jul 2019 - Aug 2022
    Mm2100 Industrial Town Cikarang, Bekasi
    PT. PHC Indonesia (PHCI) - Formerly known as Panasonic Healthcare IndonesiaAct as a Model leader of Biomedical product for Medical Deep Freezer (MDF) and Medical Pharmaceutical Refrigerator (MPR) including it's service parts with responsible as following :1. Handling new product transfer from Japan Headquarters to PHC Indonesia.2. As Coordinator of the implementation of new model transfer and development (Engineering Sample/ES, Pilot Run/PR, Pre Production/PP, Acceptance Quality/AQ, Mass Production/MP) with all related department.3. Create engineering document (manufacturing document, BOM, etc).4. Mechanical problem analyze and solving.5. Control assembly unit sample in production line according to specification and control schedule.6. Checking and evaluate of New Parts, including follow up to Japan headquarters7. Verification and Validation report for New Model of Product : IQ (Installation Qualification), OQ (Operation Qualification), PQ (Performance Qualification).8. Parts & Process Development to support production capacity up9. Support Japan and local designer about part development (Redesign, modify, quality improve, finite element analysis and its simulation) continue by verification and validation through Test run in production line.10. Supplier development support about handling and improve Quality issue during new model development stage and mass production.11. Control and Drive for update and monitoring about Technical Change Notification / Specification Change of product with others department that affected during new model development stage and mass production.12. Value Engineering / Cost Reduction activity
  • Pt Patco Elektronik Teknologi
    Senior Foreman Part Engineer
    Pt Patco Elektronik Teknologi Feb 2018 - Jun 2019
    Gobel Industrial Complex Cibitung, Bekasi
    In charge as plastic molding single parts of Customer (Epson, Omron, Kawai, Suzuki), also Sub Assy product of Omron coil winding G7L-2AT model with responsible as following :1. New Model Part Approval preparation arrangement2. Conduct 4M part Approval Process 3. Analize and Drive daily abnormality Part Countermeasure and Prevention 4. Mass production of mold/dies problem control and drive 5. Analyze & Design Jig, etc. for Improvement to support Production Up6. Control Part QCD new model and current 7. Support Production Capacity Up and keep good Quality through Setting parameter improvement during massproduction8. Daily 4M part progress update 9. New Model Progress update10. Cost reduction activity
  • Pt Air Surya Radiator
    Engineering
    Pt Air Surya Radiator Feb 2017 - Feb 2018
    Bekasi, Indonesia
    Job Responsibilites :1. Design and make the calculation about specification requirement of radiator/heat exchanger product based on clients/customers requested that refers to international Technique standard such as; ASME, ASTM, ANSI, API, AWS, etc.2. Created as built technical drawing by CAD based on spesification data of client and design data of product. Also preparing of Bill of material / Bill of quantity material of product.3. Created and preparing of engineering document such as ; tender document, drawing, project report and its supplement document.4. Remodelling/ remodify and measuring of product as customized by client/customers requirements.5. Distribution technical drawing of product to all departments.6. Monitoring the progress project from the begining untill finish and handling about quality issue in production/durung fabrication that related with engineering department about design product.7. To coordinate and control all the members of the Department of Production 8. Responsible for the overall production of technical problems.9. Engineering Document Control
  • Pt Nw Industries
    Production Engineer
    Pt Nw Industries May 2014 - Jul 2014
    Cibitung
    Job Responsibilities :1. Make a concept and drawing using CAD of boiler and all its instruments.2. Checking the design and instruments are based on technical standard spesification(ASME, ASTM, ANSI, etc.).3. Make a list of BoM / BoQ of drawing based on technical standard spesification.3. On site project to backup the project engineer make surely the designs are precise with the drawing from the begining until finishing project.4. Monitoring the progress project on site project to make some evaluation and report progress project for engineering department.
  • Gunadarma University
    Laboratory Asistant
    Gunadarma University Sep 2013 - Jun 2014
    Universitas Gunadarma. Bekasi
    1. To Assist and monitoring the practicans in any laboratory activity.2. To keep the tools and materials of laboratory which good condition and ready to use,3. Assesment the practicans and reporting, and input into database academic,4. Evaluate for the improvements in the future of laboratory to be better.

Rachmat Shaleh Education Details

Frequently Asked Questions about Rachmat Shaleh

What company does Rachmat Shaleh work for?

Rachmat Shaleh works for Virtue Diagnostics Indonesia

What is Rachmat Shaleh's role at the current company?

Rachmat Shaleh's current role is Mechanical Engineer | Process Engineer | Design Engineer | Manufacturing Engineer | Quality Engineer.

What schools did Rachmat Shaleh attend?

Rachmat Shaleh attended Universitas Gunadarma.

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