Post Job Free

Resume

Sign in

Clinical Operations Project Manager I/II/III

Location:
Spencerport, NY
Posted:
January 20, 2024

Contact this candidate

Resume:

Steven R. Niedziela

** ***** ****, *********, *** York 14624

Cell: 714-***-****

E-mail: ad2yfx@r.postjobfree.com

OBJECTIVE

I recently moved to Rochester, New York from Southern California and am seeking a highly challenging position in the Rochester, New York area or Remotely from my home office that will allow me to use my extensive dynamic experience and abilities to increase your profits and prove goals or ideas previously deemed impossible.

SUMMARY

Point-of-Contact, Imagineer Mechanical Engineer, Design Engineer and Project Engineer of capital projects for the leading theme park in the world, The Disney Company at Disneyland, Anaheim, California. (Page 4)

With little or no supervision, direction, or information, responsible for Project Research, Scope of Project, Budgets, Plan, Design Engineer, Resource Allocation, Teams, Timing, Manufacturing, Facilities, Operations, Scheduling and Construction to completion. (Pages 2, 3, 4, 5)

Personally responsible for up to 17 projects at a time, ranging from $50,000 to $23,000,000 in scope, lasting in duration from one day to several years, in an on-call 7 x 24 environment. (Page 2, 3, 4, 5)

Research new techniques, products, software, suppliers and vendors for Commercial and Industrial projects.

Make recommendations, obtain letters of credit, and coordinate with purchasing. (Pages 2, 3, 4, 5)

Responsible for staff meetings regarding any and all operational issues, from design and construction thru safety including Americans with Disabilities Act Legislation and Ride Operations. (Page 2, 3, 4, 5)

Substantial experiences as a Project Engineer / Design Engineer utilizing AutoCAD, SAP and Maximo software. (Pages 2, 3, 4, 5)

2 University Degrees in 3 Majors.

University level matriculating credit hours thus far: 202 (7 years) (Pages 6 & 7)

4 Internships: United States Federal Congressman, New York State Senator, American Bar Association and United Kingdom’s House of Commons in Parliament, London, England. (Page 6)

18 years piloting aircraft: Single Engine Land, Sailplane & Hang Glider. (Page 9)

Licensed & Bonded Notary Public in the State of California. (Expired) (Page 8)

6 Federal, State and City Business Licenses. (Page 3)

Substantial Professional Experience in Semi-Conductor, Mechanical Engineering, Entertainment, Construction, Manufacturing, Government, Clinical Research, Battery & Energy Industries. (Page 2, 3, 4, 5)

Please refer to the following pages for additional detailed information.

Page 1 of 9

Steven R. Niedziela

PROFESSIONAL EXPERIENCE

Cytex, Corona, California & Rochester, New York 8/2001-Present

Project Engineer, Mechanical Design Engineer, Project Manager & Quality Assurance Manager to conceptualize and develop mechanical special Commercial and Industrial equipment, including Facilities and Utilities. Produced and checked layouts, details, Bill of Materials and assemblies. Coordinate fabrication, prepare budgets and managed with onsite installation. Interface with foundries, machine shops, sheet metal shops, quality control & quality assurance.

Company Types:

Construction Facility / Utilities Management: new construction utilizing 43 Concrete, Steel & Electrical Building Standards with 400+ Codes & Guidelines (Li-Cycle Inc.).

Medical: (Viasys / Pulmonetic Systems, Rochester Clinical Research for FDA Human Clinical Research Trials for new Phase 1, 2, 3 & 4 drugs).

Military: Air Cargo for Civilian and Military aircraft: utilizing FAA & AIDA Standards (Nordisk Aviation).

Hospitality: Fire Codes, Utilities, Facilities, OSHA, Labor Laws (Hyatt Regency Hotel).

Energy / Petroleum: (Shell Oil / Criterion Catalyst / Varco).

Manufacturing / Food Production: utilizing FDA Regulations Bottling / canning, and case packaging (Can Lines). Utilized AutoCAD 2005, Inventor, Solidworks, Maximo, SAP and ANSI Y14.5.

Wrote Patent for military & commercial airliner Universal Loading Devices (ULD).

Designed Ergonomic devices licensed by Food & Drug Administration (FDA).

Designed next generation FDA approved LTV 1200 mobile respiratory

Life Support inhalator for those with a trachea.

Performed extensive dynamic laboratory research analysis for FDA approval.

Rochester Clinical Research LLC / Atlas, Rochester, New York

Regulatory Department and Quality Assurance Department Manager

Department Manager for 2 FDA Regulatory Specialists and 1 Quality Assurance Specialist.

Certified and Trained in FDA, IRB, GCP, HIPAA, HSP, QMP, Advarra, Clinical Conductor, QRS, Clinical.ly, CRIO, CITI Program software systems.

Responsible for 59 human clinical trials from the drug companies, Abbott Labs, Syneos Health, Novo Nordisk, Merck, Pfizer and GlaxoSmithKline,

Hyatt Regency Hotel, Rochester, New York

Chief Engineer in a fast paced on-call 24 hour / 7 day environment.

Responsible for all 7 engineers, all engineering, utilities and facilities of 341 room luxury hotel, 3 commercial kitchens, 14 conference rooms, 4 restaurants, 3 bars, swimming pool, exercise room, 9 elevators and 3 Otis escalators in a 29 story skyscraper.

Obtaining Quotations, creating Purchase Orders, for capital projects from outside contractors.

Responsible for Guest Satisfaction thru engineering facilities, Heat Pumps, Water Pumps, Boilers, Roofing maintenance and creation of preventative maintenance systems, Standard Operating Programs, including programming of security systems, utilizing Assa Abloy, SafLok, DormaKaba security systems including ScheduleFly, HyattGeo, Excel and Word software programs.

Page 2 of 9

Steven R. Niedziela

Li-Cycle Incorporated, Rochester, New York

Mechanical Quality Control / Quality Assurance

Represented Owner’s interests at HUB to ensure 43 Standards (ASTM, ACI, OSHA, ASME, SAE, etc) and mechanical engineering documentation was being built on construction site to all Specifications and Codes between the engineering group Hatch hired and the General Contractor MasTec and various Subcontractors.

Wrote daily inspection analysis and reported to management resulting in Request For Information (RFI’s) and Non-Conformance Reports (NCR’s).

Inspector of Piping, Steel Erection, Rebar, Soil Density, Concrete Pours, Thermal Analysis, Laboratory Reports and Excavation utilizing multiple software programs.

1st in the World construction of a Spoke to Hub to Recycle / Extract Lithium – Ion Battery elements Lithium, Cobalt, Nickel, Manganese, Iron, Cadmium, Phosphorus, Aluminum and Copper Elements for Supply Chain.

Dirt Cheap Movers, LLC, Corona, California 3/2004-Present

Principal Project Manager and Owner to operate, design, program, calculate, and develop a successful fully functioning General Freight, Office and Household Goods transport company licensed and insured based in Southern California and operating in all 48 Continental States of the Unites States.

Released the 1st ever “customer-led” fully automated Instant Flat Quotation and Reservation System on all formats of desktop, smartphone and tablets at dirtcheapmover.com in May 2007.

Average workorder $866.

Completed 817 workorders in 365 days.

Licensed with the California Public Utilities Commission ( CPUC & BHGS ): CAL T 192601, USDOT: 3475625, CA: 613441, MC: 1429859, City of Colton, California 66262, California Secretary of State LLC Entity 202*********.

11 Direct W2 Weekly Payroll Employees.

Developed own Domain, Server, Social Media Verification, Encryption, SSL Password Protected, GPS Tracking, Wrote Multiple Profit Analysis Programs, and Automated Reminders to Clients.

90% of all Repeat Business generated within the 1st 5 years.

Led and Managed all required Business Banking, City, County, State and Federal Licenses, Regulations, Laws and Tariffs.

Implemented Google Cloud Based PHP Database with an HTML5 user experience in both Landscape and Portrait orientation.

27.98 percent profit margin.

North Division Reconstruction Project

Amoroso Construction Company, Incorporated (General Contractor)

Harris and Associates (Project Management)

Valley Transit Authority (Owner) Silicon Valley, Mountain View, California 8/2001-3/2002

Mediator, Project Manager and Change Order Manager to coordinate 100% of all Change Orders to $23,568,000 Federal government construction project. Build and reinforce relationships of trust to resolve construction change orders generated by owner. Settle construction, financial, legal and technical conflicts under high-speed pace and emotionally driven environment to 72 subcontractors, 3 inspectors, 2 architects, 3 Foreman and 4 Project Managers hired by owner and report directly to owner. Creation of high load concrete tarmac. Determine common denominators between parties to focus on specific issue of conflict and arrive at resolutions to prevent Time and Material (Force Account), and lawsuit claims against all parties. Prevailing Wage Union via Caltrans cost accounting. RFI’s, RFQ’s and Monthly Report creation and submittals.

Resolved 57 change orders in first 90 days that resulted in Change Order

issuance to all parties worth $3,422,048.

Key point-of-contact with signature authority of all change orders.

Directly responsible for 958 individual change order payments as of February 2002

worth an additional $5,636,011.

Page 3 of 9

Steven R. Niedziela

The Disney Company at Disneyland, Anaheim, California 3/1996 – 8/2001

Imagineer, Project Manager, Mechanical Engineer and Problem Solver to design, develop, analyze and test attraction vehicles, modify facilities and utilities, conveyors, mechanisms, sensors, throughput, safety, reliability, ergonomics, esthetics and theme, while maintaining 3 Axis G-Forces for guest satisfaction utilizing AutoCAD and SolidWorks solid modeling software in a team environment. Extensive experience in A.D.A. (Americans with Disabilities Act) legislation implementation.

Promoted to Attraction Program Management - Engineering, as key point-of-contact, with signature authority of Attractions: Pirates of the Caribbean, Splash Mountain, Haunted Mansion, Fantasmic!, Tiki Room, Swiss Family Robinson Treehouse, all Main Street Vehicles, Tom Sawyers Island, Small World, Keel Boats, and the Columbia and Mark Twain vessels.

Promoted from Ride Systems Engineering as key engineering team member responsible for all interfaces with machining operations and manufacturing.

Project Manager and Design Engineer of unique electro-magnetic brake caliper system for all Snow White and Pinocchio vehicles resulting in a record annual throughput increase of

107,309 more guests and downtimes reduced 82%.

Project Manager and Designer responsible for redesign of Splash Mountain

log vehicles resulting in a 42% throughput increase.

Promoted to Attractions Engineering team overseeing capital expense projects in attractions Roger Rabbit, Matterhorn, Splash Mountain, Peter Pan, Mr. Toad, Haunted Mansion, Space Mountain and Small World.

Supervised 4 Designers.

Orange Engineering and Machine Company, Incorporated, Anaheim, California 4/1993 - 3/1996

Project Engineer / Mechanical Design Engineer / Tooling Engineer to develop and interface fully automated laminate press, lay-up and breakdown special machine systems to enable clients to produce composite circuit boards for semi-conductor industry. Technical designs are developed utilizing AutoCAD release 12 software. Developed and applied mechanical and electrical safety sensor systems.

80% of my plant layout design sales proposals to our clients resulted in signed contracts.

Team member of worlds first 24 opening hot press.

Member of team to design and build first ever Clean Room

dual copper / caul plate puller / cutter / inserter machine.

Key engineering team member to Sales and Marketing to design and propose

100% of all plant layout designs to our clients.

Promoted by CEO to assist Director of new Automation and Material Handling Division.

Supervised 4 Designers.

Page 4 of 9

Steven R. Niedziela

Engineering Companies Employed with while Working Through College, Rochester, New York 8/1988 - 4/1993

Fast Fold, Incorporated

Hauser Corporation

F.B. Pease Company, Incorporated

Proven Designs, Incorporated

J.L.P. Enterprises

Peres Consulting, Incorporated

Mechanical Design Engineer, Engineering Manager, Quality Control Inspector, Architectural Designer and Machinist of development and manufacture of Automatic Tri-Fold Folding Machines, Chrysler transmissions, engine, suspension, body and chassis of Cadillac and General Motors new automobiles, fully automated web fed packaging machines for the medical field utilized in level 2 Clean Rooms, residential and commercial buildings, mechanisms, special machines, fixtures, fully automated 55 gallon drum openers and conveyor line single filers, operated (C.M.M.) Coordinate Measuring Machine, surface finish analyzer, operated (C.N.C.) Computerized Numerical Control and manual mills and lathes utilizing AutoCAD release 10 and CADKEY v3 wireframe modeling software.

Improved Chrysler assembly time of transmission component manufacture by 800%, quality control by 300%.

Designed a successful apple feeding mechanism that was added to production machines.

Developed 1st food grade pneumatic 55-gallon drum opener approved by the F.D.A.

American Manufacturing and Technology, Incorporated, Rochester, New York 8/1985 - 9/1989

Principal Engineer and Mechanical Designer of jig and fixture, tool and die assemblies, special machines, creation of mechanisms, process and cost analysis; programming CNC Amada / Pega turret press, I.S.O. (G-code) language; sales, plan job expense reports, quoting and purchasing. Operated CNC vertical mill, CNC brake press, turret press and shear. Produced parts for new vehicles and computerized equipment.

Awarded 2 patents by U.S. Patent Office for security and drive system of a

unique vending machine on behalf of Ness Precision Products.

Designed foolproof device to release pressure prior to General Motor’s fuel injector removal.

Lent via subcontract 2x each to AC Rochester / Delco Products & Alliance to

develop their independent projects, detailed below.

AC Rochester / Delco Products, Rochester, New York

Mechanically designed improvement in performance of automation spring / brush assembly system lines for decklid and window lift motors for new automobiles.

Alliance Mold Corp., Alliance International, Alliance Tool Corp, Rochester, New York

Designed and detailed mechanical, tool and die, jig and fixture, robotic, pneumatic, hydraulic, electronic and conveyor systems to produce a lithium battery facility in Jnjilane, Yugoslavia, printer head assembly, stake and form mold machine for integrated chips.

Raytheon Service Corporation

Consultants & Designers

State University of New York at Alfred, Rochester, New York 5/1984 - 8/1985

Drafted and detailed mechanical assemblies for high-speed copiers, detailed parts for the Strategic Defense Initiative program ( SDI ) Star Wars Program.

Designed structural and mechanical assemblies for its environmental resource recovery facility.

Freelance Draftsman- provided topography, mapping architectural drawings to

2 University Presidents involving research.

Page 5 of 9

Steven R. Niedziela

FORMAL EDUCATION

University of Rochester, Simon School of Business, Rochester, New York January 2024- April 2029

Professional Masters of Business Administration Degree PMBA, Expected April 2029

Graduate-Level executive business courses in a team environment.

State University of New York at Brockport, Brockport, New York 1989-1993

Bachelor of Sciences Degree, Double Major, Graduate of Delta College December 1992

100% 300+ series core courses, requires testing for acceptance into the advanced level university.

State University of New York at Alfred, Alfred, New York 1982-1984

Associates of Science Degree May 1984

Major: Drafting Specialization: Industrial Piping Engineering

Rochester Institute of Technology, Rochester, New York 1990-1992

Major: Mechanical Engineering, Packaging and Programming CAD Language: AutoCAD Release 10

Brunel University Law School, London, England 1991

Major: English Legal System / Law (overseas study program)

Executive / Legislative Internship, Palace of Westminster, Parliament, London, England 1992

Researcher for the Honorable Barry Sheerman, Esquire, Shadow Minister, Member of Parliament, House of Commons, Parliament, London, England, including F.B.I. (USA) and Home Office (England) security clearance.

University of Rochester, Rochester, New York 1990-1992

Major: English, Pre-Law

Monroe Community College, Rochester, New York 1988-1989

CAD/CAM I & II Language: AutoCAD Release 10

Judicial Internship Staff Member, Rochester, New York 1990

American Bar Association: Pre-Trial Release Corporation

Legislative Internship Staff Member, Rochester, New York 1989-1990

Honorable United States Federal Congressman John J. LaFalce

Legislative Internship Staff Member, Rochester, New York 1989

Honorable New York State Senator Ralph Quattrociocchi

The Disney University, Disneyland, Anaheim, California 1997

Team Foundations, Team Recognition, Team Business Focus, One-on-One Feedback, Building Interpersonal Relations, Team Decisions, Team Brainstorming, Team Building, Team Meetings.

The Disney University, Disneyland, Anaheim, California 1998

Leaders Pathway to Performance Excellence

The Disney University, Disneyland, Anaheim, California 2000

Lifelong Learning, Systems Thinking, Coaching, Reward & Recognition, Hiring and Interviewing.

The MSC Institute of Technology, Costa Mesa, California 1998

Linear Static Normal Modes and Buckling Analysis Using FEA MSC/NASTRAN for Windows Certified

Page 6 of 9

Steven R. Niedziela

SolidWorks Training and Support Center, Irvine, California 1998, 2004

SolidWorks Fundamentals Certified

Advarra University, Columbia, Maryland 2023

Extensive Clinical Trials Software Training & Certification

Formal Education Synopsis: University level matriculated credit hours thus far: 202 (7 years)

Computer Languages & Software Fluent In:

Construction SharePoint, SAP, Maximo, AUTOCAD Release 10, 12, 13, 14 & Mechanical Desktop 2000 & 6, CADKEY 3 2-D & 3-D, CADKEY 7 2-D, Programming ‘G’ Codes (I.S.O. Language), Basic, WordPerfect, MS Word, E-Mail, Windows 95, 98, NT, 2000 & XP Professional, Internet, Intranet, Outlook Release 98, 2000 & Express, Office 2012, Microsoft 365 & Microsoft Office Professional, Excel, SmartSheet, Assa Abloy, SafLok, DormaKaba security systems including, HyattGeo, Advarra, Clinical Conductor, QRS, Clinical.ly, CRIO and multiple others.

Engineering & Business Software Trained in:

SOLIDWORKS 1998, 1998 Plus, 1999, 2000, 2001 Plus & 2003, 2004, 2005, AutoCAD Inventor 5.3 & 10,

AutoCAD 2002, 2004, 2005, MSC Nastran & Cosmos 7.0 FEA (Finite Element Analysis), Construction Primavera P3 e/c & Primavera Expedition.

Software Certifications:

Certified and Trained in Federal Food & Drug Administration (FDA), Institutional Review Board (IRB), Good Clinical Practices (GCP), Health Insurance Portability & Accountability Act (HIPAA) Certified, Human Subjects Protection (HSP) Certified, Quality Management Plan (QMP) Certified, Advarra Certified, Clinical Conductor (CC) Certified, QRS Certified, Clinical.ly Certified, CRIO Certified, Collaborative Institutional Training Initiative (CITI Program) Certified.

Page 7 of 9

Steven R. Niedziela

HONORS, AWARDS AND LICENSES

Dean’s List, State University of New York at Brockport, Grade Point Average 4.00 1991

Dean’s List, State University of New York at Alfred, Grade Point Average 3.82 1982

All-American Academic Award in Cross Country, State University of New York at Alfred 1983

Gates-Chili High School Best Overall Annual Departmental Industrial Arts Award 1982

#1 of 527 competing students.

Gannett Rochester Newspaper’s, 1st 2 time winner, Carrier of the Year Award, 1978, 1980

#1 of 2,197 salesmen

Gannett Rochester Newspaper’s District Sales Manager, in charge of 125 paperboys 1981

Gannett Rochester Newspaper’s, Regional Sales Manager in charge of 12 District Sales Managers each responsible for 125 paperboys 1982

Toastmasters International Award, Certified CTM (Competent Toastmaster) 1998

1st Place, Annual Hang Gliding Competition, Duration, Spot, and Bullseye, Lake Elsinore, California 1998

1st Place, Best Speaker Award (18 times), Best Evaluator Award, (15 times), Spark Plug Winner (9 times) Toastmasters International, Disneyland (voting performed by peers) 1998-2001

Notary Public, Licensed, Bonded and Commissioned with Secretary of State, State of California 2001

License #1302233, Expired April 24, 2010, Renewable.

Excellent Credit Worthiness: F.I.C.O. Tri-Score = 753 (A+)

Page 8 of 9

Steven R. Niedziela

SPORTS AND ACTIVITIES

Hang Glider Pilot, Class 4 (Advanced) rated, 407 flights, 127 solo flight hours. 1984-2000

Private Pilot, Single Engine - Land, VFR (Visual Flight Rules), 75 flights, 54 tandem flight hours. 1996-Present

Sailplane / Glider Pilot, 74 flights, 47 solo flight hours. 1996-Present

President, Elected, Orange County Hang Gliding Association, 1st ever, 5 year nomination,

personally increased membership from 35 to 69 paid members. 1995-2000

Inspector of Elections, Registrar of Voters of Orange County, Irvine, California Precinct 59041. 1996-1999

Big Brother / Big Sister Program of Orange County, Mentor of young man from 13 to 18 years old. 1996-2001

Toastmasters International, Trained Public Speaker and Presenter. 1996-2001

President, Elected, Toastmasters International, Disneyland, Mickey’s Masters. 1999-2001

President, Elected, Rochester Area Flyers Hang Gliding Towing Club. 1987

Production Manager and Disc Jockey, W.E.T.D. Radio 90.9 FM. Alfred, New York. 1982-1984

Treasurer, Elected, IRC 501C (3), Non-Profit Corporation,

Elsinore Testing of Experimental Mechanisms 2000-Present

Well Traveled – 18 Countries thus far.

Page 9 of 9



Contact this candidate