Manufacturing Process Engineer Pharma, Aerospace, Medical Devices

Mark Borkowski

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

Summary:

Manufacturing Process Engineer professional with 10+ years of extensive experience in working with pharmaceutical, Aerospace & Medical Devices companies with combination product in Manufacturing Process.

Hands-on experience in designing sequence of Operations & Procedures for tool fabrication. Process Validation IQ, OQ, PQ.

Responsible for compliance with federal and state regulations including Product Requirements Document (PRD) with Safety and Regulatory Requirements.

Plastics injection molding including Pebox & PET for catheter applications

Generated pre-engineered parts ready for assembly & fully interacted with component suppliers.

Lean Six Sigma, Black Belt Certified with high proficiency in providing pre-pilot and pilot production support including time study, continuous process improvement and quality compliance.

Involved in quality management systems (ISO 9001 and AS9100 Aerospace Standards)

Generated SOPs and Work Instructions for New Product manufacturing

While working in Aerospace Industry & Medical Applications worked in ITAR environment generating facilities layouts and industrial projects

Education:

Bachelor’s Degree, Mechanical Engineering, Minor Degree, Electrical Engineering Polytechnic University of Warsaw

Mechanical Engineering Degree Hartford State Technical College, Hartford CT

Certifications & Trainings:

Lean Six Sigma, Black Belt Certification New Horizons, Culver City, CA

Project Management Professional (PMP) Certification New Horizons, Culver City, CA

ASME Degree, Mechanical Eng. Technology Hartford State Technical College, Hartford, CT

Solid Works, Creo & AutoCAD Authorized Training Centre Digital Dimensions Inc, San Diego, CA

Plc Programming Courses Mitsubishi Programming Centre, Los Alamitos, CA

Statistical Process Control, MiniTab

Windchill PLM

Professional Experience:

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

Manufacturing Process Engineer R&D

A complete process design and development for 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, and balloon catheter, hydrophilic coated guide wire process control and drug eluted stents.

Forming, extruding, and plastics molding of polyurethane and polyethylene compliant for: bonding, welding, chemical resistance, and gas permeability, Pebox & PET for catheter applications

Performed analysis on sink and warp utilizing resin shrink rate <0.1% and viscosity rate 60-300

Mold flow and warp analysis CFD and SolidWorks flow analysis

Tested new materials utilizing Semulia Software by Abacus (FEA)

Performed urethane casting and polyurethane RIM injection molding technique with a reaction of two components achieving a high density and strength (7k psi)

Performed Failure Modes and Element Analysis (FMEA) on failed products.

Performed tool study and tool validation including reports.

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.

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

Worked with Balloon YAG laser maintenance to support manufacturing.

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 Jan 2022 – Mar 2023

Process Engineer

Generated manufacturing documentation including work instructions and routers.

Prepared redlines for CO/CR for reviews.

Utilized software Viewpoint and LHR

Generated SOPs and Work Instructions for New Product manufacturing

While working with Medical Applications worked generating facilities layouts and industrial projects

Utilized Lean Tools: Gemba Walks, 5S, Value Stream Mapping

Utilized DMAIC knowledge and generated Pareto Identify/solve problems and goals.

Experienced in cleanroom work.

Collaborated with design engineering on documentation changes.

Performed time study and motion.

Plastics injection molding including Pebox & PET for catheter applications

Improved production efficiency by calculating and analyzing manufacturing processes utilizing a formula: Load Time minus Downtime divide by Load Timed equals Production efficiency Studied Production Rate/Time by utilizing a formula: Workload Balance equals Net Available Time to Work divided by Customer Demands will give piece work time (min/piece)

Setup of Lab Equipment periodic reviews including calibration and specifications updates

Investigated equipment for a Process Deviation and generated CAPA reports.

Used Safety and Regulatory Affairs knowledge to release documentation for Ophthalmology Retina Surgery devices.

Performed Gage R&R analysis.

Designed fixtures for pre-Pilot and Pilot production.

Experience in Design Change implementation & Design Control.

Experience utilizing Design Controls for manufacturing environment.

Lab product testing including Instruments Calibration updating & Equipment maintenance.

Implemented Fixtures for Ophthalmology Surgery Device Pilot Production and a Full Production.

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 Manufacturing.

Safety & Regulatory: For the US UL60950 replaced by UL62368, for Canada CSA C22.2 IEC 62368, for the EU IEC60601 (EMC & Supply Mains, WEE). European Union compliance per RoHS Directive 2011/65/EU and Directive (EU) 2015/863

European Union REACH Compliance per EU-REACH Regulation (EC) No. 1907/2006 Prop 65.

Meggitt Sensing Systems (Aerospace), Irvine, CA Nov 2013 – Jan 2022

Mechanical Design Engineer R&D

Ability to take an ownership with high level of responsibility.

Generated SOPs and Work Instructions for New Product manufacturing

While working in Aerospace Industry & Medical Applications worked in ITAR environment generating facilities layouts and industrial projects

Performed Qualification Efforts: ATP & QTP: STR, ENV, ENDUR & EMI / RFI.

Performed analysis on sink and warp utilizing resin shrink rate <0.1% and viscosity rate 60-300

Mold flow and warp analysis CFD and SolidWorks flow analysis

Tested new materials utilizing Semulia Software by Abacus (FEA)

Performed urethane casting and polyurethane RIM injection molding technique with a reaction of two components achieving a high density and strength (7k psi)

Performed Failure Modes and Element Analysis (FMEA) on failed products.

Performed tool study and tool validation including reports.

Metal parts fabrication utilizing forming Casting & machining

LCD Display Design (In-Flight Entertainment System and Cockpit Display Panels.)

Electro-Mechanical Packaging including CCM.

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

Coordinated to build product and worked with manufacturing engineers and a shop.

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

Manufacturing Engineering to support production-utilizing Microsoft Office, SolidWorks/ ACAD, Pro-E Creo, ECN/ ECR and GD&T

Design of fuel and flame sensors, as well as TPMS for Aircraft landing gear including electrical & mechanical parts; fixtures for Production support.

Installed new ALM equipment. Designed sequence of Operations

Generated build files for ALM parts utilizing software: UP v. 2.11 (PP3DP).

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