Project Manager Engineer

SUMMARY OF QUALIFICATIONS:

* Certified six sigma black belt

* Licensed Professional Engineer (P.Eng.)

* Strong leadership skills; managed cross-functional product development teams involving all levels of technical personnel

* Creative and results-oriented

* Strong communication and interpersonal skills

* Experienced in start-ups as well as larger medical device companies

* Product development in accordance with design control requirements; implemented design control system

* Capable of managing any stage of process/product development from feasibility to market release including new product development and line extensions

* Managed European FIM (First-In-Man) clinical trials and registry

* Successfully achieved CE, FDA and MHLW approvals of Class III medical devices

* Experienced in product transfer from R&D to manufacturing

* Project scheduling, planning, personnel management and resource allocation

* Manufacturing, Quality, Regulatory and Clinical experience

* Extensive customer interface with physicians, suppliers and internal customers

* Managed Senior R&D Engineers, Project Engineers, Technicians and Consultants

* Able to communicate in French

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PROFESSIONAL EXPERIENCE:

Mar/11 – Present ev3 Neurovascular Inc. (Covidien), Irvine, CA

R&D Project Manager (Consultant)

• R&D Project Manager of neurovascular detachable coil system

• Manage and lead cross-functional teams during various phases of product development

• Develop, update and manage overall project plan and schedule

• Manage design verification and validation activities

• Lead design reviews and present project updates to senior management including risk mitigation plans

• Communicate build plans to Operations on a weekly basis

• Prepared PFMECA, Design Validation Protocol and Clinical Evaluation Report

• Track budget performance

Jan/11 – Mar/11 Consultant - Pharmaceutical consulting company, Irvine, CA

Apr/09 – Jul/10 MEDTRONIC AF SOLUTIONS, Carlsbad, CA

Senior R&D Engineering Manager

• Managed cross-functional team for development of EP diagnostic catheter

• Executed project completion in accordance with product development process

• Provided leadership during phase review process to resolve and clarify test requirements

• Monitored project progress and provided frequent updates on project status and key task priorities to senior management

• Assigned resources based on priority identified in project portfolio

• Responsible for tracking project budget

• Evaluated product performance based on defined product specifications and failure modes analyses

• Performed shelf life verification and biocompatibility studies

• Supported design transfer from R&D to manufacturing

• Prepared Design History File

• Worked with IP department to assess impact on patent portfolio and freedom to pursue

• Successfully completed project milestone of CE submission and approval

• Supervised R&D Engineers, technicians and consultants

Sep/03 – Apr/09 BIOSENSORS INTERNATIONAL, Newport Beach, CA

Manager Engineering

• Managed multi-disciplinary project team for product development of a novel coronary drug-eluting stent (DES) to support First-In-Man Clinical Trial

• Provided regular project updates to senior management

• Performed Engineering testing in compliance with Regulatory Standards to verify performance of DES components including stent, balloon catheter and drug as well as verify/validate biocompatibility, shelf-life, packaging and sterilization

• Conducted Design Reviews per Design Control Policy to verify design inputs satisfy design outputs

• Reviewed and approved pre-clinical studies to assess device safety and efficacy

• Reviewed and revised all manufacturing documentation to clinical release revision

• Prepared Clinical Build Plan and coordinated manufacturing builds for Clinical Trials

• Assisted with design of FIM clinical trial including number of patients, number of sites, control and test articles. Interacted with Interventional Cardiologists to discuss trial design. Reviewed and revised clinical documentation such as clinical protocol, IFU, Investigator’s Brochure and Case Report Form.

• Spent 3 months in Europe managing e-BioMatrix registry

• Prepared and maintained Design History File

• Supervised Senior and Junior R&D Engineers

Aug/06-Dec/07 Manager International Regulatory Affairs

• Prepared engineering test summaries in accordance with Draft FDA Guidance Document for Intravascular Stents and Delivery Systems to support U.S. IDE submission of a coronary drug-eluting stent consisting of an active pharmaceutical ingredient and biodegradable polymer

• Reviewed all engineering test protocols and reports; prepared appropriate rationales as needed

• Reviewed in-vivo summaries of all pre-clinical testing to ensure compliance of data with conclusions

• Prepared replies to Competent Authority and Notified Body regarding shelf-life of the BioMatrix I coronary drug-eluting stent currently CE approved. Assisted with revisions to the Pharmaceutical section of the CE Design Dossier. Prepared the Essential Requirements Checklist for BioMatrix I CE submission. Familiar with post-CE registration requirements in select European countries and Brazil.

• Successfully completed submission for Ethics Committee approval of the First-In-Man Clinical Trial for a polymer-free coronary drug-eluting stent initiated during a live transmission at TCT 2006. Performed site initiation activities including Physician Training.

• RA representative for the development of a polymer-free drug-eluting stent

• Prepared global RA budget

• Member of OCRA

Sep/03-Jul/06 Manager Engineering

• Managed engineering activities for new product development of coronary drug-eluting stents to support Clinical Trials including Stealth I First-In-Man, Stealth II Pivotal Trial, Leaders Registry and Bio-Freedom First-In-Man

• Prepared Clinical Build Plans and coordinated manufacturing builds for Clinical Trials

• Managed multi-disciplinary product development team

• Performed Engineering testing to support the design and development of drug-eluting stents including drug coating uniformity studies associated with two types of drug coating processes, in accordance with USP <905>. Participated in pre-clinical studies to assess safety and efficacy of drug eluting stents.

• Assisted with preparation of Class III BioMatrix I Design Dossier for CE Mark submission; participated in development of strategic responses to Notified Body and Competent Authority.

• Collaborated with Biosensors’ licensees to ensure completion of consistent CE design dossiers. Personally met with Notified Body and Competent Authority to address questions raised during review of the Design Dossier.

• Implemented a Design Control System consisting of Design Control Procedures that successfully fulfilled the requirements for ISO 13485 certification

• Prepared and maintained Design History Files for R&D projects. Prepared Design Control deliverables such as Project Initiation Form, Risk Analysis, FMEA, Design Input Document, Design Verification Protocol, Gantt Chart for tracking project timeline, etc. Administered Design Control training throughout the company. Conducted company’s first Design Review.

• Responsible for preparing project budgets. Supervised two Senior R&D Engineers.

• Presented Engineering Project Status to Principal Investigators at the Leaders Investigators’ Meeting during EuroPCR 2006. Attended ACC, TCT and JIM conferences for information on new market trends. Interacted with Cardiologists for customer feedback.

Aug/01 – Aug/03 BIOSENSE WEBSTER, INC. (Division of Cordis, J&J), Irwindale, CA

Senior R&D Engineer

• Designed and developed elastomeric balloons for treatment of atrial fibrillation; U.S. patent 7655005 issued.

• Completed Six Sigma Black Belt Certification for characterization of polymeric balloon materials including silicone and nylon as well as the evaluation of balloon shapes and sizes appropriate for Pulmonary Vein isolation accomplished by Circumferential Ultrasound Vein Ablation. Applied Six Sigma tools for selection of final Afib balloon design.

• Identified CTQ’s for balloon design by soliciting Voice of the Customer (VOC) at an Invesigators’ Meeting during NASPE Conference and a Focus Group attended by Electrophysiologists. Participated in animal studies to evaluate the feasibility of balloon catheter prototypes.

• Evaluated balloon forming technologies including LIM, blow moulding and dip moulding; designed dipping mandrels for dip moulding process and balloon tubing for blow moulding process. Investigated various balloon bonding technologies such as UV curing, thermal bonding and adhesives; developed thermal bonding process. Assessed bonding techniques for attachment of thermocouples to balloon surface.

• Implemented balloon testing within electrophysiology lab including purchase of equipment and creation of test methods

• Prepared process instructions for balloon processing. Performed balloon stability study.

• Lead R&D team in the implementation of a new Product Development Process per Quality System Regulations including preparation of Design Control documents such as a Design and Development Plan, Business Plan and Design Input Document; formulated Marketing requirements and translated into Design requirements. Conducted Technical Design Reviews.

• Supervised R&D Technician

May/99 – Jul/01 BARD PERIPHERAL TECHNOLOGIES, (Division of C.R. Bard), Covington, GA

R&D Group Leader

• Managed all angioplasty R&D projects at Vas-Cath location as well as all R&D staff including Senior Research Scientist, Engineers and Technician

• Provided project status updates to Project Review Committee

• Approved R&D expenses and responsible for R&D budget of $300,000

• Project Manager for design, development and implementation of PTA balloon catheters in accordance with Quality System Regulations. Developed XL balloons for esophageal application with a multi-disciplinary team based at different locations.

• Performed PTA balloon material characterization of nylon and vestamid

• Coordinated establishment of R&D pilot plant to achieve equivalency with manufacturing site

• Experienced in product transfer to alternate manufacturing locations

Sep/96 – Jan/99 VAS-CATH Inc. (Division of C.R. Bard), Ontario, Canada

R&D Project Engineer

• R&D Engineer for implementation of high-pressure Opti-Plast Centurion PTA balloon catheter

• Completed qualification and validation of equipment and manufacturing processes. Prepared component specifications, product performance specifications, manufacturing SOP’s, design and process FMEA’s.

• Prepared technical sections for 510(k) submission of Opti-Plast Centurion.

• Managed multi-disciplinary team consisting of R&D, Manufacturing, QA, RA and Marketing members; identified quarterly team goals and assigned resources. Coordinated motivational activities and enhanced team building. Supervised R&D Lab Technician.

Sep/96 - Dec/97 Quality Engineer

• Participated actively in the development, market release and regulatory submission of new products. Coordinator of CE Mark Project for Opti-Plast Centurion PTA balloon catheter; achieved compliance with ISO and CE Mark standards resulting in ISO and CE Mark Certifications.

• Assisted with the implementation of new balloon configuration in response to PTA balloon complaints.

• Prepared, reviewed and approved project documentation. Project Manager for process FMEA revisions.

• Trained manufacturing personnel on procedure writing.

• Coordinator of Cost Improvement Team mandated to reduce labour and material costs associated with angioplasty balloon catheter manufacture; achieved cost reduction of $200,000.

Jun/95 – Aug/96 ALLELIX BIOPHARMACEUTICALS INC., Ontario, Canada

Junior Process Engineer

• Participated in the product development of PTH (Parathyroid Hormone) for treatment of osteoporosis; optimized downstream process design and unit operations.

• Performed pilot plant experiments for process scale-up in the areas of fermentation and purification of PTH; familiar with membrane technologies as viable purification methods.

• Collaborated in technology transfer for contract manufacturing.

• Assessed process economics by developing Bill of Materials.

• Experienced in GMP packaging for clinical trials.

EDUCATION: UNIVERSITY OF OTTAWA, Ottawa, Ontario, Canada

M.A.Sc. Chemical Engineering

(Thesis Topic: Effects of Solute Polarization on the Hydrodynamics Within Membrane-Fluid-Solute Systems, with Special Application to Hollow Fiber Bioreactors)

B.A.Sc. Chemical Engineering (Magna Cum Laude)

B.Sc. Biochemistry

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