Terry Wolf, MSME, BSEE

Placerville, CA ***** ■ 916-***-**** ■ ac5sm9@r.postjobfree.com ■ US Citizen

Objective

Challenging position as: COO; CTO; Engineering Management; Manufacturing; Design & Development Engineering & Management; System Hardware, Mechanical, Electrical & Disposable Engineering; Testing & Management; in high technology industry including Medical device and Healthcare; Facilities & Plant Management

Areas of Expertise

Areas: COO CTO Engineering Management Design Engineering Manufacturing Engineering Quality Engineering, Control, & Assurance Test Engineering Creative Innovative Solutions Production Control Customer Service Plant &Supply Chain Management

Testing Methodologies: Module/Unit Testing Integration Testing System & Functional Testing Validation & Verification Testing Alpha Testing Beta Testing Facilities Management

Testing Protocols: Test Plan Test Procedure Defect Analysis

Key Skills

Management: Strong Leadership & Management experience & skills in Engineering, Manufacturing, Production, and Quality Engineering, Control, Assurance & Testing, Facilties and Plant Management

Engineering: Experience & knowledge of all aspects of Design Engineering including Electrical, Mechanical, Disposable & Materials Science Engineering

Production: Manufacturing Engineering, Production line Planning, Design, Control & Management, Material handling and Management, Machine shop, Welding & Sheet Metals, Injection Molding including design of Molds & Fixtures,

Quality: Quality Engineering, Quality Assurance & Quality Testing, Design of Text Fixtures, Failure Mode and Effect Analysis (FMEA), Root Cause Analysis (RA), Risk Management (RM), Quality Inspection, Quality Assurance Training, Timely Safety Audits, Defect Analysis & Tracking, Design Reviews, Verification & Validation (V&V), and Design Transfer

Regulatory: ISO 13485 & FDA 21 CFR 820, ISO 9000, OSHA, UL, CE, Safety & Sanitation Standards and Practices

Computer Skills: Windows OS including 10, NT, CE & DOS, Microsoft Word, Excel, Power Point, Paint, Photoshop

Others: HVAC & Refrigeration,High Vacuum, Plumbing, Mining & Milling, Electrical & Electronics, Hydraulics, Power Generation and Distribution, Machine Shop, Welding.

Education

Master of Science (MS), Mechanical Engineering, USAF Institure, Madison, Wisconsin

Bachelor of Science (BS), Electrical Engineering, USAF Institure, Madison, Wisconsin

Experience Summary

Over 30 years of experience including, 20 years of experience in medical device and Healthcare industry, Cryogenic, Aerospace and Chemical & Plastic, Facitilies and Plant Management

Excellent leadership, communication and people skills including team building and problem resolution.

Proven track record of completing projects within allocated time and budget and rescuing troubled projects.

Successfully define and implement Design, Manufacturing & QA methodologies and best practices including requirement specifications, design analysis & review, and verification & validation testing.

Successfully define and implement QA processes and methodologies including verification and validation for FDA compliance and ISO certification.

Partial List of US Patents

Sprayer for fibrin glue (5,759,171)

Fibrinogen processing apparatus, method and container (5,750,658)

Method and apparatus for cryogenic storage of thermo-labile products (5,638,686)

Rapid cooling through a thin flexible membrane (5,557,943)

Fibrinogen processing apparatus, method and container (5,520,885)

Device for fractionating constituent components of a substance/blood using Cryo-precipitation (5,261,255)

Device for thawing frozen transfusion material and method therefore (5,243,833)

Rapid cooling through a thin flexible membrane (5,168,712)

Plasma storage freezer and thermal transport device (5,103,651)

Some international patents, and patents not available or pending at this time.

Relevant Professional Experience

Chief Operating Officer, Quantum Engineering Inc. Rancho Cordova, CA 2015 to Current

Managed R&D and Engineering development of new products in emerging technologies involving application of Quantum devices covering broad ranges of commercial applications.

Championed the company values: transparency, integrity, people centricity, teamwork, respect and fun; and develop relationships with offshore colleagues/clients to provide clients with a seamless service.

Promoted and sustained a supportive learning environment with our R&D Team.

Ensured staff are thoroughly briefed and trained prior to the introduction of new processes to ensure implementation complies with the exacting requirements of the companies goals, so that customer satisfaction / quality improvements / cost savings are delivered to plan.

Ensured clear and accurate communication is cascaded throughout the operational teams, and that good communication links are established with onshore and offshore colleagues, and clients.

Identified and supported strategic initiatives and project manage same.

Managed contract vendors, supervised and directed in-house and remote production facilities & plant management, supervised 100’s of employees.

Managed supply chain and vendor compliance and qualification for on time and multi international distribution.

Monitored quality and on time schedules insuring compliance with all regulatory and financial requirements.

Reviewed and completed all various reports and prepared all documentation advising and informing upper management on status and progress on current and proposed projects.

Prepared intellectual property documents and patents ensuring top product security and universal coverage of proprietary information.

Managed the implementation of the operational plan for to ensure meeting its contractual requirements with its clients within the agreed time frames and develop and deliver budgets / forecasts from a P&L perspective.

Senior Director of Manufacturing Engineering at SynGen Inc. – Sacramento, CA

2012 to 2015

In charge of Design, development and testing of advanced cell separation devices and accessories for production of enhanced cell therapy products to aid regenerative medicine. Manage a group of mechanical, electrical/electronics, disposable, hardware and software engineers to support two product lines viz. cell processing and cell washing. The main responsibilities include innovative design, development of disposables and maintenance of software, hardware and firmware for these products.

Provided Project leadership and management of deliverables.

Solely responsible for implementing the SynGen Quality system from ground zero per the FDA and ISO 13485 Guidelines.

Responsible for getting FDA Approval for SynGenX-1000 System for Cord Blood Processing.

Solely responsible for getting CE certification for SynGenX System for Cord Blood, Bone Marrow and PrP processing.

Solely responsible for managing and implementing design and development of all product including cell processing and washing.

Supported quality system activities, leading to improved compliance with corporate policies, 21CFR 820, ISO 13485, the Medical Device Directive, UL, CE, OSHA, FDA, and other applicable regulatory agencies.

Procured required manufacturing equipment and parts.

Managed contract vendors, supervised and directed in-house and remote production facilities and employees.

Reviewed, developed and updated Quality System documents for ISO/QSR compliance as required.

Reviewed validation protocols, manufacturing procedures, and quality plans as required.

Identified and implemented opportunities for continuous improvement.

Identified and drove continuous quality improvement in area of responsibility. Provided guidance on risk management activities including Failure Mode Effects. Analysis or Fault Tree Analysis, determination of risk hazards, and development of risk reports.

Understood and was able to review quality records to verify information is correct and complete and that specifications have been met.

Successfully managed production activities so all orders were shipped on time.

Investigated and implement ideas for quality improvement, increased productivity and cost reduction.

Championed quality initiatives.

Managed documentation of and training on production procedures and work instructions.

Recommended and executed quality improvements for production and product quality.

Defined manufacturing performance standards and reviewed the outcome of performance goals to set future targets.

Routinely improved product quality and reduced delivery costs.

Directed improvements in safety, product quality, service and cost efficiency.

Directed the manufacturing process and operational efficiency procedures to achieve goal of first run capability.

Determined suitable crewing requirements, scheduled employees and worked with Human Resources to meet changing production schedules.

Met aggressive production and safety goals while minimizing equipment downtime.

Managed product quality to guarantee compliance with quality policies, procedures and systems.

Escalated safety and quality issues and initiated remedial actions promptly.

Maintained up-to-date knowledge and information about technology and plant & facility management best practices.

Thermogenesis A Bio-Medical Co

1988 to 2010

R&D Engineering Manager, Senior R&D Engineer, Manufacturing Engineer Technical & Support Engineer, Engineer of Bio-Med systems. Supervised and directed a team of engineers, and sub contactors in the planning & installation of environmental control systems and medical device systems, HVAC & plumbing and electrical systems nationally and internationally, Facilities Management..

Additional Relevant Experience:

Inner Circle Mining Co./ Insta-Cool Inc

President & CTO of a Technology & Resource Development Company

Negotiator and Administrator, Plant Facilities & Equipment Manager,

Discovered and operated lode and placer mining sites in Northern and Southern Calif. Developed High Performance Ultra Rapid Flash Freezing Systems & Computerized Controls Systems.

Property Maintenance Manager Beauchamp Enterprises

Supervised and administered all the facilities maintenance and operational requirements for 5,000 apartments, Dana Point Marina, and 20 dental offices throughout southern California.

Data100/DEC

Electronic Design & Component Engineer, Specifications & Standards Engineer.

Parker Hannifin An Aero-Space Co

Designer & Project Manager

C5A Fire Inerting System Electronics & Mechanical systems.

Airco Cryogenics

Production Control & Manufacturing Manager High Vacuum & R&D Engineer for Cryogenic Systems, Pumps, Turbo-Expanders, Helium purifiers, LN2 Freezers, CO2 Pelletizers.

Advanced Kinetics A Physics Co.

High Vacuum & R&D Engineer for Lasers, Super Conducting Magnets & High Performance Detectors, Inferometers, Bolometers, Spectrometers & In Orbit Satellite Sensor Systems.

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