John Sisson

Project Quality, Process & Validation Engineer

*** ** **** ****** **** Raton, Florida

203-***-****

Email: abjnby@r.postjobfree.com

Education

Trinity University B. S. Mechanical Engineering

Professional Engineer License - Manufacturing Engineering (California)

Employment Summary

Over 25 years of Project, Bio Medical Engineering, Validation, Product

Research/Development, Quality and Process engineering experience in the

Medical industries involved with product development, manufacturing,

validation and qualification, development of Products, Design of

Experiments, Protocol authorship and controls, validation plans, Testing

methods and all aspects of manufacturing and computer controlled processes

and procedure development for components and assemblies.

My background includes a high level of expertise in the disciplines of new

and upgrade product design, Quality controls, test engineering and

experiments, ISO 9001 and 13485, Lean Manufacturing, cGMP, Project and

Proposal management, Statistical Process Controls for data defined problem

resolution, PLC and software controlled Automated/Robotics, manufacturing

techniques and interfacing controls as well as Test Engineering, Tooling

and Fixture methods

. Project level responsibilities for the quality and process

development of Spinal implants and instruments, design verification

and validation activities, full spectrum testing and product

launch.

. Project commissioning and validation responsibilities for surgical

components, medical devices and sterilization processes required

for coordination of product validation activities across several

divisions.

. Design/Device History File, MDD preparation and maintenance as well

as the selection and monitoring of all testing phases (mechanical,

shipping, aging and full functional)

. Development and implementation of manufacturing, R&D protocols,

Design Controls and Quality validation plans in accordance with

Quality Specification Requirements (QSR's)

. Responsible for IQ, OQ, & PQ of equipment, process and top level

product PLC controlled manufacturing processes used for

Pharmaceutical operations and medical device producing and

controlled equipment.

. Development of Validation plans and quality controls per FDA CFR

Part 21 and versed in GAMP, GAMP 4 and GAMP V methodologies.

. Assist and ensure compliance with Regulatory Affairs.

. Performed "Retrospective, Concurrent, Prospective" validations for

medical device and components, extremely knowledgeable of aseptic

and sterile manufacturing processes.

. Developed and performed process validations of mechanical and

electronically (software) controlled subsystem components and

assemblies.

. Very experienced in the areas of In Vitro and Susceptibility

testing for Bio medical devices, Drug/Devices, (Stents, Grafts),

Polyglycolic implants for fluid retention applications.

. Instrumental for new product development, process development and

sustaining improvements and project responsibilities for successful

prototypical development, manufacture and subsequent validation and

certification of medical devices, surgical components and

pharmaceutical processes and procedures.

. Continuous quality introduction through Lean Manufacturing, Six

Sigma and ACE programs in addition to ongoing monitoring and

improvement through all necessary mechanical and statistical check

procedures.

. Responsible for implementation of manufacturing plans, development

and implementation of process procedure improvements and quality

control plans, procedures and programs necessary for manufacturing

and successful certification of medical devices as required by FDA,

CFR and CAR regulations.

. Well versed with statistical tools such as Mini-Tab and SPC to

analyze inconsistencies and monitor correct production flow goals.

Professional History

02/10 to Present: Medtronic Inc Spinal Implants and Biologics Div. Memphis,

TN

Design Quality engineering lead for product development of new implant

devices and instrumentation for the in process phase cycle of "Schilla" and

"Tether" implants. This is a cross functional position and requires

leadership for product design, specification of testing, DOE's, development

of DFMEA's, PFMEA's, CFMEA's and all supporting documentation and efforts

leading to phase completion and product launch. Process development,

material evaluation/suitability, all phases of mechanical/physical testing,

trials and validation/qualification activities. Additional responsibilities

consist of both individual contributor and group lead for the definition of

validation and quality parameters, review and approval of all protocols and

guiding the execution and reporting of results, (final and summary

reports). Resolution of deviations, CAPA's and all "in line" observations

pertaining to the quality and validation functions.

10/09 to 02/10: Stryker Medical Kalamazoo MI.

Project Quality and Process Engineer with responsibilities in the areas of

implant and Class III product/device development and validation,

conformance tracking resolution of discrepant issues and CAPA's, non

conformance evaluation and disposition. Overall activities consist of

process/equipment validation, (IQ, OQ and PQ), and technical support to

operations and accessories units for continuous improvement, resolution of

manufacturing and assembly issues, daily and weekly metric monitoring,

process and work flow improvement and implementation for lean manufacturing

and MRB authority

08/08 to 10/09: Teleflex Medical Corp. Everett, Ma.

Program/Project leader for a full validation remediation effort for an

Intra-Aortic Balloon Pump and Catheter system. This effort led a team of

(8) validation engineers, in house quality and mechanical engineers to

develop and retrospectively create all supporting documentation for test

equipment, production equipment, software validation and documentation,

life cycle development, creation of Functional Design Specifications,

Catherization and Susceptibility testing, Gap Risk assessments,

FMEA's/PFMEA's, Trace Matrices, SOP's IQ, OQ, PQ's and DOE (engineering)

studies for all sub components to ensure on going capability and compliance

with FDA requirements and audit representation. Resource allocation for all

phases of the program and technical support to all mechanical, electrical

and software teams

04/07 to 05/08: Cordis Bio Medical Structures Warwick, R.I.

Senior Project engineer for a Qualification/ Validation effort focused on

the identification and certification of vendors for the production of a

newly developed Class III medical device. This position has encompassed

both provision of technical support for Product development, bio-

compatibility testing, and logistical guidance for all qualification and

validation activities and proper quality and engineering development

towards achieving certification. The focus of this effort has required a

through knowledge of product development, test methodology, validation

principles and methods, Quality documentation and techniques as well as all

aspects of Supplier chain management and surveillance pathways. Provision

of technical guidance for the performance of (retrospective) TMV Gage R&R

methods for both equipment and process parameters to determine input vs.

output.

11/06 to 04/07: Stryker Orthopaedics Div. Mahwah, NJ

Project Engineer for Cervical, Interbody vertebral and Thoracolumbar

implants and instrumentation. Responsible for the overall design and phased

development approval for activities pertaining to both trial, testing and

documentation collation, (materials, test parameters, clinical

input/changes), and DHF maintenance, presentation for approval to FDA

representatives and product launch.

9/05 to 11/06: Becton Dickenson Franklin Lakes, NJ.

Program Engineer responsible for comprehensive development of manufacturing

strategies and process documentation for surgical, disposable products and

sterilization/cleaning processes and implementation. Position has required

development and coordination of process, product and software controlled

documentation and equipment for validation activities across divisions in

Utah and Puerto Rico for the successful qualification and "Release for

Sale". Design/Device history file preparation, presentation and selection

and monitoring of all testing phases (mechanical, shipping, aging and full

functional). Assigned to validation effort to upgrade, develop and generate

manufacturing plans, equipment, and process validation documents, summary

reports, test method and test method validation procedures for medical

Class 1 devices. Position has required a thorough knowledge of

manufacturing methods and planning, test procedures, validation principles,

test data analysis, protocol preparation and final report generation.

Provision of technical assistance to both in house and vendor supported

operations Provision of technical guidance for the performance of TMV Gage

R&R methods for both equipment and process parameters to determine input

vs. output for automated equipment and surgical components.

5/01 to 09/05: Respironics/Novametrix Industries Wallingford, CT

Quality/Process Development Engineer responsible for the design, prototype

product development and associated protocol generation and execution of PQ,

IQ and OQ's for validation of Transcutaneous sensing devices, both product,

cleaning, temperature mapping and equipment and sterilization packaging for

products during fabrication and shipment. This position has required a

through knowledge of manufacturing products and techniques to be used in

sterile applications as well as fabrication in Class 10 & 100 clean room

environments.

3/95 to 05/01: Emhart Medical. Windsor, CT.

Senior Engineer in charge of all process and quality engineering aspects of

new product development for cardiovascular neurological monitoring systems

for custom designed systems for the medical industries, inclusive and both

static and dynamic controls and monitoring systems designed for such

application as oxygen transfer and "scrubbing" systems and components

applicable to the transfer and regulation devices of biomedical. Required

continuous interface with customer and government regulating authorities to

ensure highest standards of quality and manufacturing were met through the

implementation of (CFR/FDA/GMP Regulations, Duties include bid preparation

for marketing sections, after-market support, producibility review and

approval of all R&D drawings, assembly procedures and techniques as well as

all phases of traditional project and product management, including budget

maintenance and selection and maintenance of technical quality and

manufacturing engineering support to all sub-contract vendors and

manufacturing facilities, national and international. Responsible for

implementation of new product production line, including capital equipment

justification and facility layout.

11/83 to 03/95: Ohmeda Medical Devices Corporation Columbia MD.

Lead Quality engineer responsible for implementation of all Class II and

III medical manufacturing and quality control procedures and programs

necessary for manufacturing and successful certification of a new "infant

radiant warmer" system. This position required the establishment of all

traditional quality check systems as required by cGMP/ FDA/ CFR regulations

in addition to an ongoing and monitored assurance program for all phases of

the program from development through system article production. This

position also encompassed responsibilities for the new product development

of invasive surgical probe and extraction tips and end devices utilized in

the removal of arterial blockages and tumorous substance extraction. These

responsibilities included program control with respect to budgetary

controls and constraints, staffing parameters, quality assurance goals as

well as the provision of technical support and advice to Design and

Manufacturing Engineering departments for the evaluation and selection of

proper bio-compatible materials, processing parameters. Assistance in the

production environment critical for "clean" room rated processing areas and

checkpoints. This was a coordinated programmatic effort between in house

and vendor certified and supplied subassemblies and as such, assumed both

in-house and off site continuous quality and manufacturing approval

controls.

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