Project Manager Medical Device

AHMED A. HELMY

Los Angeles, CA **********@********.***

310-***-**** Linkedin http://www.linkedin.com/pub/ahmed-helmy/0/80b/aaa

SUMMARY

Versatile professional and manager with significant experience and technical skills with proven accomplishments in Class I, II and III medical devices. Strengths include maximizing relationships, energizing the workplace, driving for results and achieving set goals. Brings focus on most value adding activities quickly and creates value with minimal resources

• Leadership • Program Management • Project Management

• Six Sigma/Green Belt • Problem resolution • Change management

• IT integration/Management • Manufacturing automation & IT integration • Communication

• Team building • Operations excellence • Metrics

• Design For Six Sigma • Design For Manufacturing • System re-engineering

• Implementation • Robotics, Electro-mechanical systems • Training

• Quality Management • cGMP, QSR, ISO, EU, CE • Relationship building

• Strategic alliances • Compliance 21 CFR 11 and 820 • Performance analysis

PROFESSIONAL EXPERIENCE

Abbott Medical Optics (A division of ABBOTT Laboratories) – Santa Ana, CA 2009-2012

Ophthalmic Medical Device and Eye Care Company.

Program Engineer III

Responsible for Program Engineering and technical leadership of various Implant R&D projects. Program Engineering involves Automation technical leadership, product life cycle support from inception until commercialization.

Technical Program Management

• Managed complex integrated cross-functional, multi-disciplinary programs and project plans starting from project charter, schedules, milestones, budgets and resources

• Identified and resolved risks, mitigated issues, and ensured success.

• Managed product design control activities including design reviews, technical reviews design Verifications and Validations.

• Supported new product and systems transfer from R&D to production including I,O, PQ and Verification and Validation (V&V’s).

• Applied Design For Manufacturing Assembly (DFMA) and Design For Six Sigma (DFSS) principles to ensure viable consistently high quality product.

• Designed using CAD software assemblies and components

• Managed external and internal consultants

• Managed the transfer from R&D to manufacturing in Puerto Rico manufacturing facilities

• Successfully led the efforts with the legal department in the negotiation and development of long term licensing and collaboration agreements with key strategic technology partners.

• Provided support for training / development of project team members.

Project Management

• Prepared projects monthly, and quarterly reports and presentations, updating budgets, performed projects analysis and updated delivery schedules as needed, utilized Project Management tools such as MS Project, and Planview.

• Provided support for product costing and financial assessment of project.

• Conducted project presentations for team meetings, senior management updates, New Product Committee (NPC) and Continuous Improvement Projects (CIP) Committee.

• Ensured the project compliance to applicable regulations and quality standards.

• Ensured smooth transfer of project knowledge and technology from engineering to production.

Automation Implementation

• Led major Robotic and Automated Systems development programs including system specification development, software, software program development and systems integration.

• Built strategic alliances with technology partners to collaborate in resolving automation challenges.

• Led the efforts to source Automation vendors and contributed in the selection of the winning bid.

Product Development

• Worked with end users, Physician partners and their staff to develop various prototypes, proof of concepts and alternative designs; Adjusting for Human Factors

• Managed the development and commercialization of precision injection molded products through the entire life cycle, including part design, prototyping Mold development and release, injection molding process determination, molding process control and acceptance parameters identification (SPC), Verification, Validation and release

• Created and maintained devices history documentation to contribute to the intellectual property position of the company via invention and patent applications.

• Carried out complex or novel assignments requiring the development of new or improved techniques or procedures.

STAAR Surgical Co. - Los Angeles, CA 2004-2009

Ophthalmic Medical Device Company.

Sr. Project Manager R&D (2006-2009)

Responsible for the support of research, development, support for STAAR’s Implantable Medical Devices and their Delivery Systems. Transfer from R&D to manufacturing, scale up, post marketing review and collaborate to resolve regulatory submission issues and compliance. Support with Regulatory Affairs for new product 510K submissions

Project Management

Worked with consultants, and various vendors to design new Medical Devices injection molding tooling, Validated and then Release it to Manufacturing and scaled up

Built Risk Management document Set (Hazard ID, FMEA, PFMEA, Risk Management report etc.)

Rallied for project budget allocation and Managed granted budget

Product Development

Designed device components, assembly fixtures and tooling using CAD tools, SolidWorks and AutoCad

Utilized rapid prototyping (SLA), and evaluated models and prototypes with end users, clinical technicians and physicians.

Collaborated to transfer from R&D to manufacturing

Successfully released 3 510K Medical Device products, all were injection molded products, the last being Epiphany IOL delivery system which utilized snap fit to assemble its components (Utilizing tolerance and fine tolerance stack tuning). This expedited its manufacturing floor assemble cycle as well as eliminated the need to utilize bonding agent which facilitated its FDA clearance. This product is currently considered the company’s flagship IOL delivery device.

Managed various CAPA and Audit responses

Manager, Manufacturing Engineering, Operations (2004-2006)

Responsible to provide engineering support to manufacturing lines to insure continuity of supply while improving yields, improving quality, maintaining compliance and decreasing operational cost.

Contributed and helped to clear STAAR from an FDA 483 warning letter that was holding the company back

Reengineered delivery device manufacturing lines, increased yields by 12%. Introduced novel processing approaches which increased product quality resulting in decreased customer complaint rate by 77%.

Implemented operations excellence (6 sigma/lean manufacturing) to keep the company at a competitive advantage through leading-edge technology implementation and optimization of various developments and manufacturing processes for cost and quality. Value Stream Mapping of Operations and Information flow. 5S implementation. Kanban Implementation.

Insured all Operations and Engineering SOPS are valid and compliant to various manufacturing processes including aseptic processing for critical products.

Performed and Managed V&V on production processes.

Led and was subject matter expert for CAPA resolution and Risk management (included comprehensive FMEA’s) efforts

Debugged Injection Molding issues from molding process determination and molding process impact on part dimensions to tolerance and tolerance stack analysis

Performed and Managed the performance of Mold V&V, Mold decoupling form injection molding press and release to manufacturing

Iris Diagnostics - Los Angeles, CA 2003-2004

IVD Medical Device Company, A Division of IRIS international Inc

R&D Sr. Systems Engineer

Responsible for resolving complex Electro-Mechanical Software controlled systems engineering issues to launch a new automated IVD medical device, the iQ®200 Automated Urine Microscopy. Resolved systems engineering issues which include vision systems, flow-cell technology, fluidics, micro-fluidics, Software, mechanical, firmware, and the transfer from R&D to manufacturing and regulatory submission support and compliance.

Developed core opto-electronic CCD camera-based vision/optical system including lighting and lensing; Designed and implemented a laser based flow cell profiler. Supported R&D for product definition and design including Subassembly design, Architecture, Robotic Sample handling, Software design, Mechanical Design, Electrical design, System enclosures and integration. This was done utilizing LabView for system simulation and debugging.

Developed complex laser based surface inspection electro-mechanical vision system to inspect the flow cell microfluidic channel to ensure laminar flow enabling the iQ200 vision system sample detection

Performed V&V on the iQ200 and the developed surface inspection system.

Developed system kitting procedures reducing system build time

Amphora Discovery Corp. - RTP, North Carolina 2001-2002

A Start-up Biotechnology early stage drug discovery company

Sr. Manager, Engineering

Responsible for the Micro-fluidic High Throughput Screening complex Electro-Mechanical systems implementation, operational support and maintenance serving drug discovery. Built manufacturing operations, including IT infrastructure, data harvesting; Enabling biostatisticians and scientists’ data mining and analysis.

Supported R&D life science for method/assay development, system integration and/or system applications development

Validated (DQ, IQ, PQ and OQ) all of the newly installed equipment, which led to the proper installation, operation, and performance of the newly installed equipment and instruments as well as, finally, a viable quality product.

Developed, in cooperation with inert-disciplinary team members, including scientists and other members, Standard Operating Procedures (SOP’s) for High Throughput Screening manufacturing.

LUMICYTE, INC. - Fremont, CA 2001-2001

A Start-up Proteomics Biotechnology company

Director of Engineering

Hands-on” responsible for the design, development and implementation of automated manufacturing systems in High Throughput Screening (HTS) serving drug discovery. The work was done observing FDA regulatory requirements. Managed a team of up to 6 multidisciplinary engineers. Managed outside vendor activities. Maintained the operational status of systems

SPECIALTY LABORATORIES - Los Angeles, CA 1999-2001

A Clinical Reference Laboratory

Engineering / Project Manager, Information Technology

Responsible for the modernization and automation of Specialty Clinical Laboratories operations from specimen accessioning to analysis and result release. This was done by integrating automated sample processing systems and advanced IT infrastructure which enable physician Direct Connection Interface (DCI) to the laboratory nationally. All the work was done within compliance with 21CFR Part 11, cGMP, CLIA, GAMP, GLMP and GMP guidelines, rules and regulations.

DUKE ENGINEERING AND SERVICES - Boston, MA 1998-1999

Engineering services and consulting company

Project Manager / Senior Engineer

Conceptualized and implemented solutions for client projects. Projects included Global implementations for SAP supply chain terminals, regulatory compliance advanced systems and Y2K assessments & mitigations

MODULAR VISION SYSTEMS, INC., Montreal, Quebec 1997-1998

3rd part added value supplier, systems integrator and vision systems solutions provider

R&D Manager

Conceptualized, re-engineered, upgraded, and directed manufacturing automation solutions utilizing complex electro-mechanical systems (Industrial or Custom Robots with Vision Systems).

• Managed development of new products for Laser Vision; and assisted robotic welding (software applications, including welding control and QC applications).

• Developed a modular Controller Area Network system (which is a Distributed Control System) for a rapid cost-efficient-system deployment. Decreased the primary company product base cost by 8%; and decreased the after-sale installation and maintenance requirements by 15% (hardware and software).

MCGILL CENTER FOR INTELLIGENT MACHINES (CIM), Montreal, Quebec 1994-1997

Engineering academic center of excellence

R&D Research Engineer

Developed and implemented in “C” and “Assembler” the Real-Time motion control algorithms for the external CIM clients; as well as introducing some new technologies. Authored, co-authored, and published four scientific papers (force feedback, motion control, graphical user interfaces, applications, and the space station’s new Canada robot arm).

MCGILL CENTER FOR INTELLIGENT MACHINES (CIM), Montreal, Quebec 1989-1994

Engineering academic center of excellence

Engineering Graduate Student

Conducted cutting edge technology Research and Development in the areas of Robotics, Intelligent Systems, Vision Systems, Real Time Operating Systems, Embedded System, and Parallel Computer Processing

Canadian Bank Note Inc., Ottawa, Canada 1992-1992

Securities printing company

Project Engineer (short term contract position)

Responsible for increasing production throughput utilizing automation and production operations streamlining methodologies

EDUCATION/TRAINING

MS, Mechanical Engineering (Robotics and Automation), McGill University, Canada

Diploma Operation Research, Alexandria University, Egypt

BS, Industrial Engineering, Alexandria University, Egypt

Order of Engineers of Quebec Professional Engineers Association

Project Management training, McGill University and Duke Engineering & Services

PMI certification: In progress (PMBOK)

PUBLICATIONS PAPERS/PATENT APPLICATIONS

a. P.R. Belanger, P. Dobrovolny, A. Helmy, and X. Zhang Estimation of Angular Velocity and Acceleration from Shaft-Encoder Measurements, The International Journal of Robotics Research, 17: 1225-1233, November 1998.

b. H.D. Taghirad, A. Helmy and P.R. Belanger, Intelligent built-in torque sensor for harmonic drive systems, Proceeding of the 1997 IEEE Instrumentation and Measurements Conference, 2:969-974, May 1997.

c. IOL insertion system with Semi-Automatic trailing haptic configuration management, Application number: 12/773,653 Publication number: US 2011/0276054A1 Filing date: May 4, 2010, Pub. Date: Nov 10, 2011

SKILL SET

Computer Skills:

Computer systems: IBM PC or PC-compatible, Apple Macintosh.

Operating Systems: MS Windows, Apple OS

Software packages: MS Word, MS Excel, MS Project, MS Power Point, Visio, JMP, Minitab, Matlab, LabView, AutoCAD, SolidWorks, ProEng., Planview (Enterprise Project Management)

Engineering Skills:

• Mechanical design in 2d/3d using AutoCAD, SolidWorks.

• Tolerance determination and analysis (including tolerance stack analysis0

• Gauge R & R

• Electrical/Electronic complex systems selection design and integration.

• Electrical/Mechanical systems integration and development.

• Pneumatic & Hydraulic systems election, design and integration.

• Material, Polymer selection

• Injection molding.

• Prototyping and rapid prototyping..

• Human Machine Interface (HMI) design and implementation.

• Design for Human Factors

• Design for Manufacturing (DFM), Design for Manufacturing Assembly (DFMA)

• Design for Six Sigma (DFSS)

• Medical Device Failure Mode and Effect Analysis (FMEA), Risk Analysis (Risk management) and Mitigation.

• Production process determination.

• Sample size determination

• Statistical Analysis

• Product line layout design.

• Kaye Validator, temperature mapping

• Integration of Information Systems (IT, LIMS) into production line.

Project management skills:

• Good level of project management skills.

• Effective communication, presentation and documentation skills.

• People management skills.

• Pareto charting

• Pivot tables

Quality and regulatory compliance skills:

• Good level of engineering, verification, validation and process development knowledge.

• Risk analysis/management, FMEA process.

• Knowledge of Statistical analysis / SPC system.

• Knowledge of Six Sigma methodologies.

• Design of Experiment for process development.

• Knowledge of GMP, Quality and Regulatory requirements for medical industry.

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