Portfolio

In 2022, ME supported a developer and manufacturer of medical devices with development of a portable ozone generator medical device with mechanical design and prototyping services. Specifically, we: 

• Provided detailed cost estimate for our services. 

• Participated in design review meetings, providing input on manufacturability of initial 3D model.

• Expanded in-house fabrication capabilities to meet project needs. 

• Selected aluminum and steel alloys and dimensions to meet structural needs and minimize total product weight.

• Fabricated 120 aluminum sheetmetal parts to build three prototype units.

• Developed a set of local suppliers to provide small quantities of goods and services, including: 

  • Powdercoating

  • Alodine treatment

  • Waterjet cutting

  • Welding

  • Sheetmetal bending

• Contributed written design improvement feedback during design review meetings held after completion of each protoype. 

• Translated design improvement requests into sketches, then CAD drawings, and finally prototype assemblies.

• Documented part designs with hand sketches and CAD software, and prepared formal design packages.

In 2023, ME contributed to the implementation of a quality management software uniPoint within an ISO13485-accredited developer and manufacturer of medical devices by:

• Supporting development of validation protocols

• Methodically executing validation protocols for multiple modules, documenting results in controlled test reports.

In 2022, ME supported the change control process within an ISO13485-accredited quality management system at a developer and manufacturer of medical devices by:

• Organizing efficient meetings with key stakeholders to develop alignment around reasons for, and scope of changes, and to collect technical information critical for documentation.    

• Writing concise summary of and rationale for change sections within change request forms, for electrical and mechanical product changes.

• Evaluating specific changes against Health Canada significant change flowchart. 

• Circulated documentation for review and approval by internal and external parties via Adobe Sign. 

• Proposed form and process improvements.

Between March 2020 and October 2021, Zach worked full-time with a team of engineers and contract manufacturer within an ISO13485 QMS environment to rapidly develop reliability and production capacity of a highly complex portable life support system product, MOVES SLC to fulfill a surge in demand caused by COVID-19. This project received much public attention, read more here. Specific contributions to this project by Zach, which represent experience and capabilities now offered by Mazurek Enterprises include: 

• Consolidating equipment used in production for controlled transfer to contract manufacturer

• Purchased new and rented calibrated electrical test equipment including leakage current testers and regulated power supplies.

• Developed new test procedures and test jigs independently, and in collaboration with other team members. 

• Created and maintained end-of-line quality test procedure, and personally tested hundreds of units of product before delivery to customer. 

• Reported weekly on failure trends in production testing to top management.

• Investigated root causes of quality issues and worked with engineering personnel to develop solutions, including new assembly and test procedures, and supply controls. 

• Developed a job ad, performed interviews, and trained an assistant.

From the period between 2019 and 2021 in which Zach held a Test Engineering role at Thornhill Medical, some notable responsibilities and projects completed include: 

• Sourced, operated, and contracted calibration and repair of controlled equipment including patient simulators such as the Fluke Prosim 8 and Ingmar Medical ASL5000 breathing simulator, and other electrical and mechanical test equipment i.e. electronic loads, leakage testers, digital multimeters. 

• Prepared medical device test subjects for V&V activities, such as a mobile life support system composed of approximately 1700 parts and 5 major sub-assemblies, by repairing, modifying, and qualifying through full assembly/disassembly, sourcing parts, soldering, cutting viewing ports, installing in-line switches and valves, executing production test procedures. 

• Improved reliability of a ventilator calibration process by creating a procedure, wiring harness, and test setup for characterizing and pairing gas flow sensors prior to their installation.

• Determined shelf life for consumable products such as breathing circuits, carbon dioxide scrubbers, and carbon air filters by creating and executing stability testing protocols, and writing formal controlled reports documenting results. 

• Supported 4th edition IEC 60601-1-2 EMC pre-scan testing at an electrical testing lab, with product operation knowledge, and by documenting findings. In particular, some of the tests supported were: 

  • Enclosure Port Immunity to RF Wireless Communications Equipment 

  • Electrostatic Discharge Immunity 

  • Immunity to Conducted Disturbances Induced by RF Fields

• Designed and built a small electromagnetic vibration table to support investigation of a ventilator product quality issue, which was appearing only after product shipping. 

• With a team of engineers, methodically disassembled and tested an anesthesia delivery medical device which failed in service, to understand root cause of failure, documented and communicated findings. 

• Updated and executed design verification and validation test protocols after hardware and software changes to all of the five major subsystem PWAs of a mobile life support system. 

• Developed a test procedure for the service manual of a medical device designed to treat carbon monoxide poisoning, to evaluate three critical system characteristics to determine whether the device required service. 

• Within an accelerated timeline of just three weeks, delivered an improved production ventilator calibration procedure and custom test jig, to achieve improved calibration quality and process reliability.

In 2019, Zach contributed to the development of a set of service kit products for a portable life support system, MOVES 300. 

• Developed a new multi-test fixture concept in collaboration with engineering personnel.

• Designed test fixture to minimize initial cost and maximize serviceability by minimizing number of custom parts and cables.

• Sourced parts and materials required to build test fixtures. 

• Liaised with internal Engineers and Technicians to make the required custom parts and deliver the assembled test fixture within a tight timeline.

• Contributed written instructions, photos, test files, and feedback on others' work during collaborative effort to develop a set of production test procedures. 

• Developed validation protocol for test fixture, and performed validation.

In 2016, at a masking tape production plant, Zach designed parts for and managed the implementation of a solution to an issue causing production downtime and requiring frequent operator intervention. Rolls of masking tape expected to roll down an inclined table would frequently lodge against guide rails, requiring an operator to stop production and manually dislodge these. A solution already proven nearby was to install a vibrating motor on the underside of the inclined table. Specific tasks completed by Zach for this project include:

• Designed a safety gate latch system and inclined table using SOLIDWORKS software.

• Updated electrical schematics to include new vibrating motor using AutoCAD.

• Prepared mechanical drawing package, distributed to suppliers for quotations.

• Contracted licensed electrician and mechanical services to install the new equipment.

• Integrated vibrating motor into function block PLC programming using Schneider Unity Pro software. 

• Coordinated timing of installation with production scheduling personnel. 

• Monitored to verify effectiveness of solution. 

In 2016, in a masking tape production plant, Zach completed a project intended to eliminate downtime caused by condensate backup from electrical cabinet air conditioning units damaging electronics. Steps taken included: 

• Printed and applied serialized high visibility labels to all AC units, to aid communication. 

• Cleaned and replaced air filters, as necessary. 

• Contracted specialized service and repair of AC units.

• Selected and purchased PVC plumbing materials and condensate collection buckets. 

• Designed and installed reliable hard plumbing condensate drains, marked locations for condensation collection buckets, marked buckets with electrical cabinet IDs to discourage repurposing.

• Created AC unit registry, including location descriptions, used for condensate bucket-emptying weekly routine.

In 2008, Zach started his first small business with the support of the Ontario Summer Company program, and the Leeds and Grenville Small Business Enterprise Centre. 

• Wrote a business plan, received business grant. 

• Completed business training

• Performed repairs and rebuilds on all types and brands of machines, including: motorcycles, lawnmowers, snowblowers, chainsaws, trimmers. 

• Operated with a satisfaction guarantee, standard

• Attended weekly meetings with local business mentors

An ongoing personal project which was started in October 2008, Zach is rebuilding his 1987 Chevrolet R10. Some major accomplishments of this project, testifying to Zach's versatility include:  

• Cut out rusted body metal including rocker panels, floors, sections of box sides, and welded in replacement panels which were purchased, or fabricated. 

• Prepared frame and full underside of body for refinishing using sandblasting, grinding, and rust converter chemicals.

• Replaced TH350 automatic transmission with a custom hydraulic clutch pedal system, and later model NV3500 manual overdrive transmission.

• Rebuilt 350cu. in. Chevrolet small block engine, approximately 400hp. 

• Installed full OTS stainless steel brake line kit. 

• Formed and installed custom fuel hard lines using 37 degree flared fittings and 3/8" OD, 0.028" wall thickness precision steel tubing. 

• Mixed, applied, and shaped body filler products. 

• Applied professional automotive primer and paint products using an HVLP spray system. 

• Designed, built, and installed custom subwoofer box and stereo.