Mechanical Engineer/Program Manager

Justin Zdeb

**** ****** ****, ***** ****, FL. ***57

Phone: 321-***-**** Email: *****@*******.***

Senior Engineer/Manager

Over 15 years of Engineering Experience

BACKGROUND AND OBJECTIVES: University of Illinois engineering graduate with a career focus in Engineering Management. Intuitively creative problem solver, with the technical and business acumen required for success.

SKILLS:

Drawing Specifications & Feasibility

Engineering Change Requests (ECR)

Product Layout & Bills of Material

Solidworks (3D)

Microsoft Office (Excel, Word, Outlook)

ISO 9000 Certified Auditor

Optimization of Manufacturing Processes

Safety Director

Plastic Injection Part and Mold Design

Automotive Design (PPAP, FMEA, MFI, GD&T, CPK)

Stereo Lithography Setup

Medical Device Design and Test

Windchill MRP

Quality Assurance (PPAP Submittal)

R & D (Lab Equipment)

Supervision of Production Staff

Structural Analysis

Sheet Metal

Trade Studies

Tooling

1st Article Inspection Drawings

Team building

Library master file management

Spray technology design with inserts

Basic mold setup

SBIR grant writing

3D printing using FDM

Received 1st US patent

EXPERIENCE:

Wellvii Inc. West Palm Beach, FL. – Program Manager 2021 to current

Maintain FDA regulated QMS system

FDA pre-submittal for 510k clearance

Involved in the planning of IRB and start of De Novo 510k submittal.

Medical Device design and review for portable vital sign device, e.g., BP, Temp., R-Rate, and Oximeter, Perfusion Index, and others

Manage other contractors in software and hardware execution timelines

Use of Teams, Sharepoint, Redmine and other software for worker execution

Use of Solidworks to help with 3D models and R&D

FMEA and Design Control

Design changes and material decisions for product development

Novus Medical Products Inc., Tavares FL. – Manager Product Development Nov. 2018 to 2021

Creation and Design of Bioreactor for growth of Stem Cells

Filed patent application with USPTO

Setup of Injection Molding Facility in Tavares, FL.

Management of employees

Involved with the design of new COVID respirator mask

Received US patent for disposable infusion pump system, patent 9849233

Omega Medical Imaging LLC, Sanford, FL – Senior Principal Engineer July 2013 to Oct. 2018

Program Manager for New Product Development

New X-ray equipment Mechanical Engineer Lead for all Electro/Mechanical Assemblies

Design of Class II Medical Devices and Sustaining Engineer following Medical Device 13485 FDA Quality Directives.

Design of Complex assemblies involving dynamic calculations

Review and scheduling of work for major Electro-Mechanical projects

Responsible for the review of co-worker’s work

Sustaining Engineering for current products

Create BOM’s, Routers, and Drawings for equipment

FEA of various parts

ECR and drawing updates

Class1/Hale Inc., Ocala, FL – Mechanical Engineer March 2012 – July 2013

Custom Design of Fire Suppression Systems

Design of sheet metal operating panels, frames, and custom brackets

Solidworks drawings and complete BOM and manufacturing specifications

Work on manufacturing floor for product improvement and increased on time delivery

GENO LLC, Cocoa, FL – Senior Mechanical Engineer June 2010 – January 2012

Design of various class II respiratory medical devices for clinical studies and data collection

Procurement of parts for commercial product release

Wiring diagrams for product specification and quotation

Part Specification using MS Office

Complete packaging design for respiratory system

Documentation updates using Solidworks

Sheet metal parts design for touch screen system with parts that include electronic board brackets and housing

Damping system for shock and vibration

Start from concept to a commercial respiratory product submitted for 510K Clearance

Contract Consultant for:

Custom Man. and Eng. Inc., Pinellas Park, FL – Mech. Eng. (11-month Contract) May 2010 – April 2011

Design of sheet metal communication system NIPR/SIPR network

A study of the production of a micro air conditioning system for US Army

Feasibility of various manufacturing processes including: injection molding, machining, casting, die casting and other techniques for proper cost reductions

Redesign and build of micro air conditioning system. Potting of system components.

Layout of electrical connectors and cabling components for UPS system using Lithium-Ion batteries

Brijot Imaging Lake Mary, FL – Mechanical Engineer (6-month Contract) Aug.2009 – Feb 2010

Responsible for the design of electro-mechanical parts, system specification, order parts for prototype build, BOM, sheet metal, weldments, and development of new products

Design of dual reducer geared motor system for system calibration

Zyberware LLC, Ocoee, FL – Mechanical Engineer (6-month Contract) April 2009 – Oct. 2009

Development, design, and testing of a prototype of a Solar Fresnel Concentrator

Over one hundred sheet metal parts and electrical schematics designed for system

Design all sheet metal components and electro-mechanical parts for manufacturability

NCR Inc., Lake Mary, FL – Mechanical Engineer III July 2008 – April 2009

Reason for Leaving: Plant closure

Design of Sheet metal parts for Electro-Mechanical assemblies

Weldment table for self-check-in Kiosk to hold 300 lbs. using FEA

Design of mounting assemblies for electro-optical systems

Coordinate with project managers on timelines and revisions based on client feedback

R & D for new products

Use of Solidworks 3-D (8000 HRS), AutoCAD (8000 HRS), COSMOS FEA, and PDMworks

Flomet LLC, Deland, FL – Manufacturing Engineer January 2008 – July 2008

Reason for Leaving: Out-of-town commute. Better, more local opportunity presented itself

Manufacture and design of precision coining apparatuses, jigs, and fixtures

Use of Solidworks 3-D and AutoCAD 2007

Design of MIM parts (Metal Injection Molding)

Troubleshoot pneumatic assembly equipment

Design and testing of Military mine switch and various medical products

Use of SPC (Statistical Process Control) on parts and forming tools

Collaborated with vendors to reduce scrap rate

Design of Basic Molds for MIM part

Use of GD&T basic dimensioning for medical products

Packaging Concepts LLC, Boynton Beach, FL – Chief Engineer May 2006 – Nov 2007

Reason for Leaving: Plant closure

R&D Designer for new products

Design of assembly tools and machines

Time studies and cost efficiency studies

Collaborated with Assembly teams to increase production and efficiency

ECO addressed with customer and QA

SOP for the induction and analysis of 1st article inspections

QC and qualification of new parts and molds

Followed GMP standards and FDA approved clean room

Directed Chinese mold makers on the making of new tooling and approved parts per specification

Worked on PLC automated equipment with bowl feeders, pick and place which are pneumatically driven

Use of Solidworks and AutoCAD. Create BOM, Assembly Drawings, Blister Packs, and necessary drawings for manufacturing

Troubleshooting of relays switches and mechanical failures

Knowledge in testing and filling of dispensers/bottles on automated assembly lines

Created master files for QC department, including layout and assembly instructions

Time Studies and Cost Analysis of all products for match-up of true costs

Developed Corrective Action (CAPA) for manufacturing problems and quality issues

Worked with mentally disabled facilities to coordinate the assembly of PCA’s product line

Discussed with sub-contractor any concerns with quality and molding problems

Provided Molding Window to sub-contractors and advice on molding

Prime Medical Products Inc., Orlando, FL – Staff Mechanical Engineer 2001 – Dec 2005

Assisted in the design and testing of a patented disposable injection molded infusion pump used for chemotherapy and pain management. Collected data for 510K Clearance

Flow rate tests

R&D Prototype design

Optimization of current design for mass production

Documentation, use of Solidworks and AutoCAD to design fixtures and parts for new products lines

Level 2 ANSI Standards

Interaction with Marketing and modification of prototypes for improved performance and image

Prepared marketing plan, sales materials and launching product

Design of injection molded product for commercial applications

Miner Enterprises, Geneva, IL Mechanical Engineer 1999 – 2001

Design, testing and manufacture of custom heavy-duty strut suspension systems for mining systems

Increased efficiency by 20% for a multi-million-dollar automotive suspension line. Redesign of molds/tooling and adaptation of new manufacturing processes

ISO-9000 Documentation/Auditor

Design of Weldments

Design of suspension casting for United Defense. Suspension was to be placed on the A1 Abrams Tank

Use of statistics to calculate the CPK operating window

Six Sigma for automotive PPAP submittal

Supervision of production crew

Product Specifications, and cost analysis

PPAP Submittal, FEA, FMEA, GD&T

Stress Analysis of axial loaded elastomeric pads and castings

Engineering Change Notices (ECN)

Mold Design and manufacturing processes of plastics

Product Layout, Assembly Procedures, QA, BOM, Routers

Managed shop individuals on manufacturing and assembly of new product lines

Used End Mill and Lathe for various prototype projects

EDUCATION:

BSGE (Bachelor of Science in General Engineering)

University of Illinois, Urbana/Champaign

Over 50 hours of Business Courses –Stetson University MBA (attended 1/3)

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