MARK BORKOWSKI, PMP, Lean SixSigma Black Belt

ad30n4@r.postjobfree.com

Irvine, Ca

CAREER OBJECTIVE

Seeking a growth opportunity with a reputable company where Project Management for electro- mechanical engineering could be utilized in the technological improvement of product and processes.

SUMMARY OF QUALIFICATIONS

•Electro-Mechanical Engineering with Medical Device experience Class I, II and III including non-invasive devices.

•A complete Project Management for new product launch including performing PM analysis, budgeting and large projects milestones tracking

•Managed Teams Successfully

•Analyzed capabilities of each team member

•Used FMEA knowledge and regression to improve PM

•Successfully managed KPI,s

•Experienced working with Cross Functional Teams in GMP, protection of environment and prevention of pollution.

•Collaborated with Teams via MS Teams including approving deliverables and releasing documentation in SAP, Windchill and Agile PLM

•Managed cross functional activities including scope, budgeting and scheduling projects utilizing MS Project and DMAIC Methodology

•Worked with vendors solving existing issues on the spot

•Built tools and fixtures for pre-pilot and pilot production

•Managed major projects from concept to market

•Generated reports for stake holders including upper management, procurement and finance

•Experienced in Technical Transfer working closely with Product Stewards during product builds

•Managed a $5 million production line development

•Managed Multiple Projects Milestones utilizing DMAIC and MS Project

•Managed product testing during development and before delivery process

•Performed analysis on Risk ISO14971 and Hazard Analysis (SHA)

•Designed a Manufacturing Process for a wire forming for Trans-catheter Heart Valves.

•Researched Ni-Ti-Co Alloys utilizing my Metallurgy knowledge.

•Managed Drug Eluting Stents project – Everolimus Program

Provided design control expertise for supply-chain driven manufacturing improvements

•Responsible for Project Management, development, and testing of all phases of the additive process with a focus on manufactured parts, cost models, manufacturing machines. Analysis. Eperience working within QMS design control processes and Knowledge of product development processes to product launch

•Generated build files for Additive Layer Manufacturing (ALM-3D Printing).

•Designed manufacturing processes for medical devices. Expertise with conduction and convection based Thermal systems design. Performed thermal dynamics and CFD analysis (Air Flow for semi-conductor systems, thermal convection & conduction).

•Strong project management, team building, and coordination skills.

•Vendor interface and qualification.

•Designed Medical Respiratory Devices including Oxygene and Drug delivery.

•Designed small handheld devices including Glucose Analyzer, Blood Gas Analyzer & Breathalyzer.

•A strong technical background within Systems Engineering, Test Equipment Development for medical devices.

•Designed Blood Gas Analyzer including a mini–Peristaltic Pump running Microliter blood samples through Array of Electro-Chemical sensors.

•Test Fixtures Design and Development.

•EVT/DVT testing including writing protocols.

•NPI Verification and Validation protocols.

•Electro-Physiology Catheter Design and Development.

•Generated build files for Additive Layer Manufacturing (ALM-3D Printing).

•High volume Production and Costing of plastics injection molding parts using heat treated tool steel: A2 & H13.

•Performed Medical Device Sterilization Processes: 220 Deg F at 20 PSI & 20 Minutes duration, Dry Heat Sterilization up to 320 Deg F including Gamma Radiation sterilization.

•Worked with a Supply Chain and coordinated all supply efforts.

•Researched Ni-Ti Alloys utilizing my Metallurgy knowledge.

•Designed a Manufacturing Process for a wire forming for Trans-catheter Heart Valves.

•Designed automated equipment for manufacturing.

•Performed Manufacturing Validation Processes.

•Vendor interface and qualification.

•Manufacturing Process integration and testing.

•Process improvement and Process Quality Audits.

•Root Cause Analysis/ Continuous Process improvement.

•Tracking RMAs and CAR for products/ Field Actions/ Supplier interface.

•Designed automated test equipment for manufacturing processes.

•Advanced skills in Electro-Mechanical Engineering utilized in new product component development and improvement of products and processes. Solid Works, ACAD, and Pro-E/CREO. GD&T, ASME Y14.5.

•Experience with Systems Engineering and requirements management.

•Statistical Analysis: Experiment’s design, Stability of process & control (MiniTab, SPC, Statistical Test Analysis: Experiment design, Stability of process & control.

•Acceptance Test Procedure (ATP) & Qualification Test Procedure (QTP) writing.

•Lab Tests: STR, ENV, ENDUR & EMI / RFI.

•Structural/Thermal Analysis, FEA.

•Enovia v. 6.0, Windchill & Agile PLMs.

•Test design experience, generating Requirement Lists, Test Plans, Test Protocols & Action Reports

•Applied Gauging Techniques & Measuring System Analysis (G&RR).

•Inspected performance of machinery for efficiency to ensure product quality.

•Manufacturing Documentation control utilizing SolidWorks PDM Works, ECRs, SPC, FMEA, Lean Six-Sigma.

•Production Automation Test design and implementation with vendor development.

•Tooling & Polymeric Plastics Injection molding Design of pumps for medical use.

•Development of Manufacturing Processes and sequence of Operations.

•Strong project management, leadership and team building & coordination skills.

•Customer and vendor interface. Design & procure tools and equipment.

•Powered Surgical instruments utilizing mini stepper & servo motors and computer-controlled mechanisms. 21 CFR section 820 & ISO 13485. Risk Management Files per ISO14971.

•Ensure safety and Regulatory compliance with FDA, GMP, EU-MDR, SPC, SIX SIGMA, ISO 9001, ISO 13824, ISO 13485, IEC 62304, ISO 13408, and IQ, OQ, PQ.

PROFESSIONAL EXPERIENCE

Abbott Vascular/ Walk Vascular, Irvine, CA 11/2023 - Present

Sr Project Engineer

A complete Project Management for new product launch and production of existing JETi Thrombectomy system to remove blood clots including performing PM analysis, budgeting & large project milestone tracking

Managed Teams Successfully

Experienced working with Cross Functional Teams in GMP environment

Analyzed capabilities of each team member

Used FMEA knowledge and regression to improve PM

Successfully managed KPI,s

Experienced working with Cross Functional Teams in GMP, protection of environment and prevention of pollution.

Developed new suppliers and verified Quality Manuals for production quality and manufacturing capability

New supplier interface and support regarding their products

Performed FAI of components coming from new suppliers

Developed new inspection tools

Trained FAI associates on new tools and new inspection methods

Updated Work Instructions (WI) utilizing Abbott software Quality Control By Design (QCBD)

Performed Abbott DCO processing for JETi Lamination operation

Improved lamination process for Laminated HypoTube Subassembly

Experienced in FDA 510k submissions, EU-MDR Gap Mitigation’s. GMP, TUV, Matlab, SPC, SIX SIGMA and ISO 9000, ISO 14971, ISO 13824, and ISO 13408. Product verification IQ, OQ, PQ.

Experienced with jigs and fixtures design including automation design (LabView) and Drawings.

Welding, Machining and Sheet Metal.

Risk Management Files per ISO 14971 including Quality Reports.

Alcon Research, Irvine, CA 01/2020 – 11/2023

Project Manager

•Managed Teams Successfully

•Experienced working with Cross Functional Teams in GMP environment

•Collaborated with Teams via MS Teams including approving deliverables and releasing documentation in SAP

•Managed cross functional activities including scope, budgeting and scheduling projects utilizing MS Project and DMAIC Methodology

•Worked with vendors solving existing issues on the spot

•Analyzed capabilities of each team member

•Used FMEA knowledge and regression to improve PM

•Successfully managed KPI,s

•Experienced working with Cross Functional Teams in GMP, protection of environment and prevention of pollution.

•Managed tools and fixtures for pre-pilot and pilot production

•Managed major projects from concept to market

•Generated reports for stake holders including upper management, procurement and finance

•Experienced in Technical Transfer working closely with Product Stewards during product builds

•Managed a $5 million production line development

•Worked with company cross functional teams regarding medical products development including generating of Product Requirements Documents (PRD)

•Lab Equipment/Industrial Equipment experience

•Lab Equipment setup and DAQ on test setup

•Performed Fluid Flow analysis utilizing CFD software and testing flow instability

•Product process and process equipment experience including pre-pilot and pilot manufacturing

•Experienced in manufacturing Clean Room work & safety rules

•Interface with internal and external customers

•Developed experiments and product improvement tests including protocols, WI’s and Test Methods

•Managed plastic injection molded parts for medical devices-high volume production including working with metals and ceramics

•Managed medical devices taking to account usability, manufacturability, safety and regulatory requirements

•Conducted clinical and feasibility studies including evaluation of concepts for fit form and function

•Evaluated suppliers and materials for medical device manufacturability

•Collaborated with teams on preparation and submission of regulatory documents

•Developed product testing methods. Verification & Validation including Protocols & Reports.

•Process and Parameters development.

•Provided design control expertise for supply-chain driven manufacturing improvements.

•Technical Transfer of Design, Product, Process, Equipment and Technology from R&D to Pilot Production and Manufacturing

•Managed automated test equipment for manufacturing processes.

•Electro-Mechanical Engineering including Medical Device experience. Designed medical devices: Class I, II and III. Electro-Mechanical Equipment Validation for Medical Devices.

Meggitt Sensing Systems (Aerospace & Medical Appl) /HCL, Irvine, CA 11/2013 – 01/2020

Sr Project Coordinator

•Ability to take an ownership with high level of responsibility.

•Provided design control expertise for supply-chain driven manufacturing improvements

•Performed Products Qualification Test Efforts: STR, ENV, ENDUR & EMI / RFI.

•Manufacturing Team coordination skills/ teamwork oriented.

•Design of Manufacturing processes, procedures & installation of production new equipment.

•Manufacturing Process integration & testing. Designed automated test equipment for manufacturing processes.

•Process improvement and Process Quality Audits.

•Designed manufacturing processes for medical devices. Expertise with conduction and convection based Thermal systems design. Performed thermal dynamics and CFD analysis (Air Flow for semi-conductor systems, thermal convection & conduction).

•EVT/DVT testing including writing protocols.

•NPI Verification and Validation protocols.

•Structural/Thermal Analysis, FEA.

•Transfer design to production including vendor development

•Performed Risk analysis and Risk Managements files per ISO14971

•Root Cause Analysis/ Continuous Process improvement.

•Tracking RMAs and CAR for products/ Field Actions/ Supplier interface.

•Worked with a Supply Chain and coordinated all supply efforts.

•Good planner with the ability to come up with the forward plans to complete tasks and resolve issues.

•Vendor interface and qualification.

•Test Fixtures Design and Development.

•High volume Production and Costing of plastics injection molding parts using heat treated tool steel: A2 & H13.

•Generated build files for Additive Layer Manufacturing (ALM-3D Printing).

•Provided weekly reports with completed / pending action items and forward plan.

•Hosted meetings with team of engineers for project status and forward plan.

•Coordinated to build product and worked with manufacturing engineers and shop floor.

•Reviewed and submitted ECRs and CAD drawings via SolidWorks Smart Team software.

•Manufacturing Engineering to support production-utilizing Microsoft Office, Solidworks/ ACAD/ Pro-E/CREO, ECN/ ECR and drawing review & submit to CCB.

•Manufacturing Engineering of fuel and flame sensors, as well as medical sensors for handheld Pacemakers & Gas analyzers including electrical & mechanical parts; fixtures for a direct Production support. Tooling & equipment development. Designed sequence of Operations & Procedures for tool fabrication. CAPA.

SANYO SOLAR (USA) LLC, CARSON, CA 1/06 to 11/13

Manufacturing Engineer

•Manufacturing Engineering, statistical test analysis and build automated equipment line for silicon wafers manufacturing.

•Test Fixtures Design and Development.

•Designed automated test equipment for manufacturing processes.

•Heat Transfer: Conduction Cooled & Natural Convection Analysis.

•Applied DFSS knowledge. Statistical Analysis: Experiment’s design, Stability of process Lab Tests. Agile PLM.

•Manufacturing Process integration & testing of new silicon wafer equipment.

•E/M production process equipment for crystal growers-manufacturing support for production.

•Lean Six-Sigma, ASME, GMP, 6S. Safety Programs, ISO14001 & ISO 9001 implementation. Risk Management Files per ISO14971.

GUIDANT CARDIO-VASCULAR, TEMECULA, CA 10/03 to 1/06

Project Engineer

•Managed design & development of class III Medical Device and manufacturing engineering (including transferring design from R&D into manufacturing), also lab equipment design for interventional-cardiology devices utilizing SolidWorks, AutoCAD, balloon catheter, hydrophilic coated guide wire process control and drug eluted stents.

•Managed Manufacturing Process for a wire forming for Trans-catheter Heart Valves.

•Researched Ni-Ti-Co Alloys utilizing my Metallurgy knowledge.

•Managed Drug Eluting Balloon Catheters – Everolimus Program

Provided design control expertise for supply-chain driven manufacturing improvements

•Managed Test Fixtures Design and Development.

•Vendor interface and qualification.

•Transfered design to production including vendor development

•Manufacturing Process integration and testing.

•Designed Medical Respiratory Devices including Oxygen and Drug delivery.

•Designed Blood Gas Analyzer including a mini–Peristaltic Pump running Microliter blood samples through Array of Electro-Chemical sensors.

•Designed Non-invasive Devices performing a Blood Gas Sensing.

•Generated build files for Additive Layer Manufacturing (ALM-3D Printing).

•Performed Risk analysis and Risk Managements files per ISO14971

•Designed manufacturing processes for medical devices: Class I, II and III.

•Process improvement and Process Quality Audits.

•Root Cause Analysis/ Continuous Process improvement.

•Tracking RMAs and CAR for products/ Field Actions/ Supplier interface.

•Designed small handheld devices including Glucose Analyzer, Blood Gas Analyzer & Breathalyzer.

•High volume Production and Costing of plastics injection molding parts using heat treated tool steel: A2 & H13.

•Performed Medical Device Sterilization Processes: 220 Deg F at 20 PSI & 20 Minutes duration, Dry Heat Sterilization up to 320 Deg F including Gamma Radiation sterilization.

•Designed automated test equipment lines for manufacturing processes.

•Electro-Physiology Catheter Design and Development.

•Forming, extruding & plastics molding of polyurethane & polyethylene compliant for: bonding, welding, chemical resistance & gas permeability.

•Experienced in FDA 510 (k), GMP, TUV, MATLAB, SPC, SIX SIGMA & ISO 9000, ISO 14971, ISO 13824, and ISO 13408. IQ, OQ, and PQ.

•Worked with a Supply Chain and coordinated all supply efforts.

•Researched Ni-Ti Alloys utilizing my Metallurgy knowledge.

•Designed a Manufacturing Process for a wire forming for Trans-catheter Heart Valves.

•Performed Manufacturing Validation Processes.

•Hydro coater 4up & 8up automation design, and assembly utilizing Yamaha linear motors & sensors w/guide wire process control to coat up to 8 guidewires.

•Worked with Balloon YAG laser maintenance to support manufacturing.

•Experienced with jigs & fixtures design including automation design (LabView) and documentation. Risk Management Files per ISO14971.

LASER MEDICAL, SAN CLEMENTE, CA 6/00 to 10/03

Systems Test Engineer

•Applied DFSS knowledge.

•Applied various test methods

•Statistical Analysis: Experiment’s design, Stability of process & Equipment testing.

•A Complete system engineering and document control of new medical products & new applications. Also, micro-camera optical fiber delivery systems with optical train design and laser hand piece design: laser head type, fiber type & airmatic type. The mini-laser heads were used for soft & hard tissue surgery. Optical fiber (200-600um) coupling using a high-power connector & Six Axis Fiber Alignment- Design with my name included in this U.S. patent PD-2171recorded in 2001 & 2002.

•Research and Development of Biomaterials.

•Performed Risk analysis and Risk Managements files per ISO14971

•NPI Verification and Validation protocols.

•Transfered design to production including vendor development

•Systems integration & testing of Medical Lasers (Nd: YAG) & 6 watts (erbium), including argon & holmium laser. GMP, FDA, TUV, CSA. 21CFR section 820 & ISO 13486.

•Statistical Analysis: Experiment’s design, Stability of process Lab Tests. Agile & Windchill PLM.

EDUCATION

Politechnical University of Warsaw

Bachelor’s Degree, Mechanical Engineering and Minor Electrical Engineering

Hartford State Technical College, Hartford, CT

Associate Degree, Mechanical Engineering Technology

New Horizon, Culver City, CA

Lean Six Sigma, Black Belt Certification

Project Management Professional (PMP) Certification

Digital Dimensions Inc, Authorized Training Center, San Diego, CA

SolidWorks and AutoCAD

Irvine Valley College, Irvine, CA

Printed Circuit Technology, Small Hole Drilling, PC Board Manufacturing, Pro-E

Mitsubishi Programming Center, Los Alamitos, CA

PLC Programming Courses.

Santa Ana College, Orange Campus, Santa Ana, CA

Small Business Management (GPA 4.0)

LANGUAGE

Fluent in English, German, Russian and Polish

TOOLS EXPERIECE

SolidWorks/ Smart Team, AutoCAD & Pro-E, MS Project, Prog: STR, ENV, ENDUR, EMI \ RFI.

PATENTS:

•A High-Power Connector for an optical fiber coupling. Patent #pd-2171 recorded in 09/2001 by Spensley & Horn Law Corporation.

•A Six-axis Micro-Mechanism for optical fiber alignment recorded in 8/2002 by Jubas & Lubitz a Law Corporation

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