Engineer Manufacturing

Edward S. Vitali

* ******* ******

Billerica, MA 01862

Cell: 508-***-****

E-Mail: ********@*******.***

Senior Manufacturing & Quality Engineer

Senior Electromechanical Manufacturing & Quality Engineer possessing a broad spectrum of

experience. Responsible for leading, defining, sustaining and enhancing complex, semi-custom

products by monitoring the production process and managing manufacturing, quality and supplier

quality issues. Adept in the use of Demand Flow Technology (DFT) and Lean Manufacturing, Six

Sigma techniques, Green belt, MIL-Spec, ANSI and FDA regulations, skilled in the use of

Microsoft Office software programs and Adobe desktop publishing software. Experienced in new

product introduction (NPI), Reliability Development Testing (RDT), leading cross functional teams,

Material Review Board (MRB) operations. Highly skilled as a technical writer in developing

detailed product acceptance inspection and test procedures, quality test plans, OMS (operational

method sheets), BOM (bills of material), work instructions and process documentation using

various desktop publishing software.

*CQI *cGMP/CFR820 *JIT *DFMA

*TQM *5S *KanBan *PFMECA

*HQMS *FRACAS *Pokka Yoke *ISO9001-2000

*ISO 13485 *ISO 14971 *FDA 820 Regulations *ANSI

Specifications

PROFESSIONAL EXPERIENCE:

1/2011 to Present

Tecomet – Senior Quality Engineer

• Responsible for the development of medical implantable and aerospace part specific

quality plans based on customer requirements using techniques such as FMEA, Risk

Assessment, Control Plans, Gage R&R, and SPC.

• Review non-conforming material for root cause, making appropriate material dispositions

and corrective actions. Leads cross-functional corrective action teams driving defects and

design flaws to closure.

• Develop quality verification plans, IQ/OQ/PQ, BOM (bills of material) and work

instructions for new and existing products to forge, machine and verify product

performance.

• Develop Lean Manufacturing within the company using Six Sigma techniques.

• Ensure compliance to ISO9001, ISO13485, AS9100 and FDA CFR820.

• Conducts and technically manages short-term or significant projects.

• Develops project plans, including methodology, schedules, budget, personnel,

equipment, materials, and supplies. Evaluates project progress, recommend and

implement corrections to ensure project objectives are met.

• Conduct and design technical experiments, analyses or tests pertaining to the

development of new methods, processes or standards, modification of current material,

component, or process specifications, and resolution to complex technical problems.

• Act as a technical resource and assist in the training and career development of lower

level engineers and support staff.

• Provide technical consultation to other Engineering disciplines, and other departments,

organizations and management.

2009 – 2011

Abiomed, - Senior Manufacturing Engineer

• Lead efforts for new product introduction (NPI) of the IMC console used in conjunction

with heart recovery and ventricular assist devices (VADs). Including test, troubleshoot

and repair of circuit boards, pumps and vacuum sub-systems.

• Implemented LEAN manufacturing processes using Six Sigma techniques and design JIT

Manufacturing for the IMC console.

• Lead Kaizen events to improve IMC inventory, and finished goods to ensure a steady flow

of products to customers.

• Develop quality test plans, IQ/OQ/PQ, BOM (bills of material) and documentation

packages for new and existing products to assemble, test and verify product

performance.

• Perform process validation, risk assessment and statistical process control (SPC) for new

and existing produces.

• Develop, edit and maintain work instructions documenting system assembly and test

procedures using Adobe desktop publishing software.

• Design and develop manufacturing processes for new products, product changes and

enhancements, and related tooling and fixtures which are consistent with a zero defect

level as well as low product cost.

• Support prototype and pilot production of new products, product changes, and

enhancements in coordination with the Manufacturing and Quality Control functions

• Participate in facilities engineering and planning.

• Assist in the introduction of Kanban 2 bin parts system for a continuous flow of

components to Manufacturing.

2000 - 2009

Brooks Automation, – Group Leader of Robot Manufacturing Engineering and Senior

Manufacturing and Quality Engineer

• Sustain and provide day to day on-floor engineering support to Brooks Automation

product lines.

• Lead troubleshooting and repair efforts for Brooks Automation robotic products including,

electronic circuitry, mechanical components and vacuum sub-systems.

• Lead multiple Kaizen events to improve product flow, system returns and the repair and

refurbishment of robotic products.

• Manage junior manufacturing and quality engineers and lead engineering efforts in

planning transitions of capital equipment from development to pilot production and on into

full production.

• Lead new product introduction (NPI) efforts for the Reliance robot from prototype to full

production.

• Lead in the transfer of new products developed in the Brooks Automation California

facility to the Brooks Automation Massachusetts Manufacturing facility.

• Assisted in the introduction of Demand Flow Technology into Manufacturing including

Just in Time and Kanban 2 bin parts supply systems.

• Develop and implement new methods of manufacturing subassemblies with resulted in a

substantial decrease in cycle time and highly improved product quality and reliability.

• Develop quality test plans, OMS (operational method sheets), BOM (bills of material) and

documentation packages for new and existing products to assemble, test and verify

product performance.

• Layout and plan manufacturing and test facilities layout and supervise installation with

Brooks Automation personnel and contractors as required.

• Lead cross function teams to investigate customer complaints and perform root cause

analysis and corrective action for internal and external causes ensure effective and timely

corrective actions are established.

• Provide leadership and electrical, mechanical and vacuum technical engineering support

in the solution of difficult production, product, and process problems and in the design

and development of Brooks’ automation capital equipment. .

• Improve total cost of quality and issues at supplier’s locations while maintaining primary

focus on piece price cost reduction.

• Initiate and monitor continuous process improvements within all Brooks Automation

product lines.

• Drive supplier process improvement through root cause and corrective action.

• Assist in supplier selection, qualification, development, transition and new product

introduction.

• Lead daily Material Review Board (MRB) meetings and coordinate activities for the

investigation and disposition of non-conforming materials.

• Ensure efficient high volume manufacturing through use of Lean Manufacturing process

improvement methods.

1998 – 2000

Comverse Network Systems, –Product Development Engineer

• Manage all phases of new product development and implementation from prototype to

production to insure that products meet customer's expectations, including the areas of

Reliability, Availability and Serviceability.

• Define customer requirements and specifications and introduce into products. Research,

write, edit, update and illustrate high quality internal and customer documentation.

1996 - 1998

MICRION CORPORATION, - Customer Support Engineer:

• Test, troubleshoot, and repair the Micrion focused ion beam system and subsystems

used in the semiconductor industry. Investigate customer complaints and determine root

cause.

• Implement FRACAS, Failure Reporting Analysis and Corrective Action System and ISO

9001.

• Establish and maintain statistical measurements of equipment reliability, availability, and

maintainability using SEMI E10-96 guidelines, and the Microsoft Access database.

1992- 1996

BEHRING DIAGNOSTICS INC. - Product Support Engineer:

• Provide technical support and service training to field service engineers, technical support

specialists and distributors for Behring Nephelometers and Fibrintimers and for the OPUS

family of Immunoassay systems. Create and implement service training programs.

• Serve as a liaison between Field Operations and, Engineering, Manufacturing and

Regulatory.

• Investigate customer complaints and determine root cause.

• Collect failure analysis data, review engineering and manufacturing developments and

technical information for product serviceability.

• Write technical documentation, manuals and procedures to support Field Operations and

Customers and assist in the implementation of ISO 9001.

EDUCATION:

Bachelors of Science Degree in Electrical Engineering - Northeastern University, Boston, MA.

Veteran of the United States Navy – Electronic warfare Class “A” and “C” schools.

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