Jamil Mogul’sPD_Profile

Including Management Experience/Style

Academic: ◦ M.S. in Mechanical Engineering from Santa Clara University,

Santa Clara, California ◦ B.S. in Mechanical Engineering Technology from Cogswell College, San Francisco, California ◦ B.Sc. in Physics/Math from Forman Christian College & Punjab University, Lahore

Patents & Publications: ◦ Over 7 Patents Issued, Three Patents Pending & Two Technical

Articles Published in Machine Design & Design News Magazines Computer Literacy: ◦ MS Office, MS Project, AutoCAD, PRO-E, Algor/FEA, Mechanica, BEAM 4

(optical ray tracing), MathCAD 5.0 plus, BASIC and FORTRAN

Leadership Skills ◦ Team Building, 90-90 Leader, Conflict Resolution, Positive Power of

Influence and Helping Others Succeed

Customer Focus Experience: ◦ Listened to Voice of Customers (Users/Physicians) ◦ Determined User Needs ◦ Prepared Customer Requirements Specification ◦ Performed Safety and Hazard Analysis (Per ISO 14971)

Regulatory Knowledge & Experience: ◦ U.S. FDA QSR-Design Controls, 510(k). IDE, PMA and PMA-S;

and ISO 13485, European Union Medical Device Directive, Design Dossier / Technical File and CE Mark

Fast-Cycle Product Development Process: ◦ Concurrent Activities of Marketing, R&D & Manufacturing ◦ Five Phases: Concept Feasibility, Specification, Development,

Pilot-Production, and Production/Commercialization ◦ Use of Design Controls (FDA/ISO) and Design History File

Program Management Experience ◦ Directed Multiple Product Development Programs ◦ Led Cross-Functional Project Teams Representing:

Marketing

Mechanical Engineering

Electrical Engineering (analog/digital/optics & power supply )

System/Software (GUI) & Firmware Engineering

Industrial Designs

Manufacturing Engineering

Quality Assurance & Regulatory Affairs

Material Management

◦ Using the MS Project Software, Planned, Budgeted, Maintained Master Project Schedules, and Tracked the Progress of the Projects and the Project Teams.

Accomplished Development Projects on Spec, on Time and within Budget

Projects Encompassed FDA Class II & Class III Medical Devices: ◦ Electro-opto-mechanical Equipment ◦ RF/Laser/Microwave Therapeutic Equipment ◦ Biomedical Instrumentations/Sensors--Diagnostic ◦ Energy Delivery Devices ◦ Minimally Invasive Diagnostic/Therapeutic Devices

Undertook Development Projects from Concept through Commercialization

Developed Over Twenty Medical Products: ◦ Laserscope dual frequency air-cooled laser equipment ◦ 4 Laserscope laser probes for endoscopic surgeries ◦ Puritan-Bennett whole blood gas analyzer (BGA) using optics ◦ Puritan-Bennett BGA calibrator using optics ◦ Puritan- Bennett disposable BGA calibrator using optics ◦ Puritan-Bennett BGA fiber optic sensor and storage cuvette ◦ Puritan-Bennett operating room monitor ◦ Puritan-Bennett oximeter using optics ◦ Siemens ultrasound equipment for echocardiography ◦ J&J blood glucose meter, OneTouch Ultra using optics ◦ 4 Boston Scientific ultrasonic/RF catheters for cardiac EP diagnosis/therapy ◦ 7 Boston Scientific steerable RF-ablation therapeutic cardiac EP catheters ◦ 2 Boston Scientific diagnostic cardiac EP catheter ◦ Boston Scientific smart RF power selector instrument ◦ 6 Mogul steerable and 8 fixed-curve diagnostic cardiac EP catheters/probes ◦ 4 Mogul steerable RF ablation EP catheters and 4 RF ablation EP probes ◦ 4 Mogul orthogonal steerable diagnostic catheters for pulmonary vein app. ◦ 3 Mogul Basket diagnostic EP catheters & 6 temporary pacing catheters

Puritan-Bennett (PB) Blood Gas Analyzer

Role: Sr. Mech. Engineer

Contribution: ◦ Mechanical design/chassis ◦ Mechanism for optics ◦ Pneumatic system design ◦ Sensor assembly ◦ Calibration cuvette design

Patents: ◦ U.S. 5187971 & U.S.5187970 ◦ My last name was not used; only my first and middle

names were used on the patents of calibration cuvette

Mallinckrodt/Nellcor acquired the PB business

Puritan-Bennett (PB) Operating Room Monitor

Role: Project Engineer

Contribution: ◦ Components selection

◦ Internal structure design

◦ Modular assemblies design

◦ Enclosure design

◦ Display frame design

◦ Keypad assembly design

Patent: N/A (Only for the electronic design)

Datex acquired the PB business

Siemens Ultrasound for Echocardiography Role: Mechanical Engineer Contribution: ◦ Components/parts selection ◦ Spatial frame structure design ◦ Monitor’s tilt/swivel mechanism design ◦ Chassis/enclosure & packaging designs ◦ Articulating arm design ◦ Counterbalance mechanism for sliding control panel

Initially, it had two monitors side by side Patent: N/A (May have been filed after I left) This was my first project at my first job

Boston Scientific Smart RF Power Selector Role: Program Manager Contribution: ◦ Led/managed a project team ◦ Represented R&D ◦ Components selection ◦ Enclosure design ◦ Internal structure design ◦ Tracked project tasks ◦ Design V&V protocols/reports ◦ Conducted safety and hazard analysis ◦ Resolved technical problems and schedule conflicts ◦ Presented the project status to the Sr. Management/CEO

Patent: N/A (Only for the electronic design) Used MS. Project and U.S. FDA Design Controls

Boston Scientific Steerable RF Ablation Catheter (An example) Role: R&D Director (at CPC) Contribution:

◦ Led/managed a project team ◦ Represented R&D Management ◦ Transition sleeve design ◦ Ergonomic handle design ◦ Tracked project tasks ◦ Design V&V protocols/reports ◦ Safety/hazard analysis ◦ Resolved technical problems ◦ Addressed manufacturing issues ◦ Presented the project status to the Sr. Management/CEO

Patent: ◦ U.S. 5984907 (at EP technologies acquired by Boston Scientific) ◦ My last name was not used; only my first and middle names were used on

the patent of the transition sleeve assembly

Used MS. Project and U.S. FDA Design Controls

Mogul Orthogonal Steerable Diagnostic EP Catheter (An example) Role: Vice President, R&D & RA/QA Contribution:

◦ Led/managed a project team ◦ Represented R&D Management ◦ Steering mechanism design ◦ Distal & proximal shaft design ◦ Distal steering design ◦ Orthogonal mechanism design ◦ Ergonomic handle design ◦ Auto & one-hand lock design ◦ Tracked project tasks ◦ Customer Requirements Specification ◦ Design Requirements Specification ◦ Design V&V protocols/reports ◦ Safety/hazard analysis ◦ Resolved technical problems & scheduling conflicts & addressed manufacturing issues ◦ Prepared regulatory submissions for all EP catheters/probes (510(k) and CE Mark)

Patents: U.S. 7269453, U.S. 7122020, and U.S. 6829497 Used MS. Project and U.S. FDA Design Controls

Watch Video Attached

Over 18 years of Director to VP Level Experience Managed up to 25 Direct/Indirect Reports (managers/engineers) Lead Diplomatically Cross-Functional Teams of up to 15 Persons Used the Team Leadership Skills and 4P Management Style of:

◦ Positive Thinking/Approach (solution-driven) ◦ Pull (bridging) ◦ Persuasiveness (technical/logical and result-oriented) ◦ Participatory Approach (including all stakeholders)

Demonstrated Flexibility—Responsiveness to Changing Needs Mentored Managers and Engineers Directed the Activities of Project Managers and Engineers Built Professional Organizations & Created Performance Metrics Evaluated Performances of Employees and Projects Presented Projects Status to Sr. Management/CEOs and Board Recognized and/or Rewarded Top Performers Met Project Commitments and Goals