Technical Operations Management and Program Systems Engineering

John Edward Steck Technical Operations Management Program Systems Engineering Marietta PA - 717-***-**** - *********@*******.***

Career Objective:

I am a seasoned, multi-disciple, industrial engineering technologist leader with high performance results in diverse industries. I am looking to focus my career on executing aggressive business revenue and profit development solutions with companies looking to push the envelope and grow developing new products, industrializing cutting edge technology, applying lean methodologies to manufacturing, and streamlining operations.

Core Competencies:

Consistently delivers lean, risk reduced results geared to meet and exceed project and business goals and requirements.

Brings to bear mature soft-skills leadership, communication, industry, manufacturing, IP, and materials experience.

Effectively blends accountability-based management techniques with hand-on technical skill sets

Specializes in resourcefully bridging creative and technical team with functional manufacturing operations.

Regulated environment compliance experience with FDA Medical Device, EPA Small Engine, and ITAR Programs

Management Skills:

Operations and Facility Development, Program Management, Risk Management, Requirements Management, Stage Gate PDP, Resource Loading, Multi-Year Business Forecasting and Revenue Planning, Product Line Road-Mapping, Design for Six Sigma, Patent Strategy, Supply Chain, Customer Engagement, Team Building and Mentoring, Direct Reports, Matrix Management, Technical and Creative Staff Management, Lean Manufacturing, Freight Logistics, Warehouse and Fulfillment, P&L, Board-level and Executive-level Briefings

Technical Skills:

Systems Engineering, Root Cause Analysis, Failure Mode Analysis, Six Sigma Statistical Analysis, cGMP FDA Regulatory Compliance, Design for Manufacture, QA/QC Metrology, IQ/OQ/PQ, Fixturing, Plastics Manufacturing, Product Sterilization, Sheet Metal, Laser & Water Cutting, 3D Printing, Direct Laser Structuring, 3D Modeling, MS Project.

Professional Experience:

COO: Energy Wall, Lancaster PA - April 2016 to December 2017

TECHNOLOGY INDUSTRIALIZATION, FACILITY DEVELOPMENT, BUSINESS STRATEGY, CASH FLOW, CONTRACTS

Developed and industrialized manufacturing processes and core technologies for a $4M capitalized private equity start-up.

Established operations, architected plant layout and production material flow, and brought critical facility infrastructure online.

Evolved corporate identity, marketing initiatives, and actively participated in customer engagement and business negotiations.

Develop multi-year financial plans, resource plans, and parallel revenue strategies to secure $2.2M in loans and investments.

Negotiated and oversaw execution of supplier contracts, non-disclose agreements, and employment contracts.

Participated as a voting member of the Board of Managers as designated representative of the common share stock.

Completed 3-year assignment in 18 months.

Lab Manager: TE Connectivity, Middletown PA - November 2012 to August 2015

SYSTEMS ENGINEERING, PROCESS INDUSTRIALIZATION, CAPITAL PROJECTS MANAGEMENT, PATENTS, ITAR

Industrialized additive manufacturing technologies for rapid development and prototyping of mobile device antenna systems.

Risk reduced complex technical problems negotiating intangibles, developing strategic alignments, and leveraging resources.

Initiated funding proposals and program managed facilities and equipment capital projects totaling over $1M combined.

Reduce engineering sample lead time from 4-6 weeks to 3-4 days to support early customer engagement initiatives.

Materially participated in securing over $300M in contract sales and achieved center-of-excellence recognition.

Awarded one of three corporate global manufacturing Speed-Up Excellence Awards in 2015

R&D Project Engineer: Surgical Specialties, Reading PA - July 2011 to October 2012

MEDICAL DISPOSABLES, MEDICAL IMPLANTS, SHARPS, DEVICE PACKAGING, GRAPHICS, IQ/OQ/PQ, PATENTS

Developed suture packaging, ophthalmic blades, ultrasonic fabrication process and equipment, tooling, and fixtures.

Generated Technical illustrations for instructions for use and materially supported 510k submissions.

Lead the industrialization of new equipment and fabrication processes to satisfy terms of a $30M product line sale.

Lead Product Development Engineer: Unilife Medical, York PA - January 2010 to March 2011

MEDICAL DISPOSABLES, MEDICAL DEVICE PACKAGING, SYSTEMS ENGINEERING, MATRIX MANAGEMENT

Systems engineering, risk management, and requirements management of safety syringes, syringe trays, and tubs.

Program managed the engineering, development, and risk reduction of three core product line needle safety syringe platforms.

Maintained regulatory compliance, lead verification studies, and facilitated design transfer to automated manufacturing.

Systems Engineering Program Manager: Baxter International, Round Lake IL - July 2006 to October 2009

MEDICAL DISPOSABLES, CLASS 3 ELECTROMECHANICAL, MEDICATION DELIVERY, PATENTS, MATRIX MGMT

Developed infusion pumps, dialysis systems, stem cell equipment, drug containers, and medication delivery systems.

Directly involved with on-site customer engagement and regulatory voice-of-customer capture.

Generated a body of intellectual property to support and reinforce market value of multiple core product lines.

Program managed multiple $100-300k R&D projects to within +/-10% of project cost, schedule, and requirement goals.

Engineering Manager: Dentsply RINN, Elgin, IL - May 2005 to May 2006

MEDICAL DISPOSABLES, DEVICE PACKAGING, TOOLING, PATENTS, DIRECT REPORTS

Designed and engineered needle hubs, cap & sheath packaging, and x-ray sensor holders.

Generated a body of intellectual property to support and reinforce market value of multiple core product lines.

Championed the implementation of structured problem solving and lean manufacturing initiatives.

Successfully lead root cause analysis of a class 2 product field failure, applied corrective action, and avoided a product recall.

Director Product Development: Echo USA, Lake Zurich, IL - October 2003 to March 2005

SMALL ENGINE POWER TOOLS, TRANSMISSION SYSTEMS, WARRANTY RESOLUTION, DIRECT REPORTS

Reduced warranty resolution time by over 50% through accountability-based goal setting.

Implemented sustainable cost reductions of $3M against $2M goal.

Generated detailed multi-year technology road maps, timelines, and budgets against company goals and objectives.

Global Plastics Tooling Manager: Motorola, Libertyville, IL - August 1996 to October 2003

PLASTICS DFM, INJECTION MOLD TOOLING, TECH TRANSFER, IQ/OQ/PQ, MATRIX MANAGEMENT

Designed, engineered, and materially supported the manufacture of over 300 injection mold tools.

Achieved Six Sigma Green Belt certification.

Wrote Motorola’s global low-volume tooling manufacturing specification

Directly supported cost avoidance of over $100M in expedited prototype tooling manufacturing charges

Materially supported local and international supply chain management.

Formal Education:

MS Systems Engineering (December 2018): George Washington University, Washington DC

Business, financial, and program management

Lean Design for Six Sigma Black Belt Training (2014): TE Connectivity, Middletown PA

Design for Six Sigma principles and lean manufacturing and operations strategy

DMAIC Six Sigma Quality Green Belt (2002): Motorola University, Algonquin IL

Six Sigma quality principles and applications

Masters Certificate in Project Management (2001): George Washington University, Washington DC

Project leadership skills

BS Industrial Technology (1990): Northern Illinois University, DeKalb IL

Engineering design, manufacturing processes, and technical supervision

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