Engineer Engineering

Mr. Jamie S. Henderson

Currently located in Eastern Europe but planning to relocate

back to the states this summer and location is flexible

US Address:

**** **** **** **. #***

Mesa, Arizona 85405

Telephone: 707-***-****

email: ****************@*******.***

EXPERIENCED

PROCESS AND PRODUCT DEVELOPMENT ENGINEER

SPECIALIZED IN IMPLANTABLE MEDICAL DEVICES and PTFE PROCESSING

With more than twenty two years of diversified and progressive experience in the Medical Device Research & Development and Process Development environments, seeks a challenging career opportunity in the field where his skills and experience can be utilized.

Summary of Skills and Experience/Qualifications:

Employ someone who has:

Taken several implantable medical devices from concept through prototype, process development, validation, scale-up into full commercial launch

Comprehensive knowledge and hands on experience of PTFE polymer processing, process development, equipment design

A proven creative thinker with demonstrated ability to harness ideas into relevant practical solutions

A prolific inventor submitting hundreds of invention disclosures throughout his tenure resulting in numerous trade secrets, patent applications/publications and issued patents

A track record of success with new career challenges

with skills and experience in:

Disease States: both Aneurismal & Atherosclerotic disease treatments, Peripheral Vascular Disease (Vascular Grafts/Shunts/Stents), Late Stage Diabetes (AV Access), Coronary Artery Disease (stents), AAA and TAA (both open surgical repair/replacement & several endovascular devices), Renal (stent),

Materials and Processes: Polymers - Dacron, Textiles, PTFE, FEP, Compounding, Extrusion (tubing, bead, sheet, film), Calendering, Expansion (md, cmd), Distension, Sintering (ovens), Silicone, Stents (self-expanding) cut tubing, wire-wound, and braided types, Nitinol, stainless steel, fatigue testing, fracture analysis, Catheter - Pebax, balloon catheters, stent deployment catheters, other - Thermomechanical analysis (DSC), SEM, specialized equipment - tooling and fixture design, induction/eddy-current thickness measurement, extrusion die design, hotwire cutting, selective sintering, graft tunneler.

Process Development activities and tools: IP protection and strategies, process characterization, design control, DOE, FMEA, Six Sigma, SPC, IQ/OQ/PQ, Value Stream Mapping, Lean Manufacturing, error proofing, yield improvements, software usage - CAD (SolidWorks, AutoCAD), Minitab, PDM, SAP, MS Office,

Leadership: strategic thinker, conflict resolution, rapidly builds rapport and morale in others, strives to create a positive and motivational environment, actively develops the skill-sets of the team members, actively strives to instill humor and a camaraderie within the company, fosters open communication, encourages team members to help each other, drives hard for results, believes that path to success is riddled with failures and hardships that you must find a way to drive through as a team.

Employment

Record

2012 January - Current LBP, Lublin, Poland

(non-medical contract work, stakeholder)

Positions Held – Project & Engineering Manager

LBP (http://www.lubelskiebiuroprojektowe.com)

Project Management – managed multiple simultaneous projects, budgeting, tracked and optimized workload, cost, schedule, resources in highly dynamic environment

Managed engineering team of specialized independent contractors (6 to 10 contractors with expected growth to 20+)

New Business Development (government contracts, new business proposals)

Equipment Design, CAD drawing modifications

Triventure Enterprises, Inc., (business owner)

Intermittent side-work and various projects (outside scope of LBP)

oContract market research and competitive edge assessment (food industry)

oStock and currency trader, financial market strategist and technical analysis expert

oFinancial model construction and optimization

oPublished author of several trading strategy applications and technical analysis articles in a widely-read publication

oStrategy automation and robotic systems

2008 April – 2012 January Trivascular Inc., Santa Rosa, California

Positions Held – Senior PTFE Engineer

Managing PTFE film department and all related activities

6 Direct Reports

Process Validation and supporting activities

Manufacturing Engineering Activities: SPC, Lean Manufacturing, Value Stream Mapping, Six Sigma, process improvements

Process Development Activities:

oRebuilt and restarted the PTFE Film Production Line from complete shut-down, disassembled and boxed state

oSolved a major long-term yield issue leading to an 80% reduction in yield loss

oDesigned technical solutions for PTFE manufacturing scale-up for short-term10x capacity ramp

oEvaluation and validation of new raw material lots

R&D Activities:

oExtrusion sheet die redesign and optimization

oActive participant in PTFE patenting activities, PTFE IP defensive strategy and IP summit

oEvaluation of technologies and suppliers

oNext generation film innovations

Assisted in solving other technical issues outside of the PTFE area:

oCompany-wide Nitinol fracture investigation, assembled and authored report

oCo-designed of a Nitinol single crown ultra high-speed testing system

oCatheter sheath failure mode investigation

2007 Oct – 2008 April Triventure Enterprises, Inc.,

Engineering and Consulting work for

Collagen Matrix, Inc., Oakland, NJ

Positions Held – Owner, Self Employed

Medical Device Process Development and Scale-up Activities

Equipment Design and Fixturing

Technical Advisor (FDA/ISO) / General Engineering Consulting

2006 Sept – 2008 Jan Boston Scientific, Wayne, New Jersey

Positions Held – R&D Engineer

Solved a major PTFE product failure issue that threatened the successful completion of an FDA driven full re-validation of all vintage processes.

Team Leader (3 Engineers and 2-3 technicians) Redesigned process recipes to stabilize process during raw material changes. Kept issue contained and improved quality and safety of the final product

Technical Advisor to other PTFE process improvement teams

2006 – Jan to Sept Boston Scientific Trivascular, Santa Rosa, Ca

Positions Held – R&D Engineer

Development activities for inline thickness measurement tool prototype

Spearheaded PTFE Film Engineering Design package

Assisted PTFE Film group in transition to Boston Scientific systems

Worked on solving ePTFE Film spec limit failure issues

2001 – 2006 Boston Scientific Medi-Tech, Wayne, New Jersey

Positions Held – R&D Engineer, Associate Engineer

Lynx Program Support

oYield Improvement tooling resulting in an increase in yields from 25% to 85%

oFinal Inspection process developed and implemented

oDocumentation Support for First Human Use of device

Designed ePTFE Graft Tunneler

oDeveloped significantly improved design over industry leader

oFavorable results for initial testing in animals

oSeveral innovative technologies developed resulting in 3 patent applications filed and 8 invention disclosures

Designed and built a new extruder die to greatly improve uniformity

Ran yield improvement program and Validation of sub-20um thin wall covering for Coronary Stent (Symbiot™)

Radial Expansion Yield Improvement tooling developed resulting in significant improvements in yield

1997 – 2001 Boston Scientific Medi-Tech, Wayne, New Jersey

Positions Held – Research Assistant

Monaco AAA device team – prototype devices and equipment design support

Equipment design and procurement

Vacuum fixtures

Bifurcated silicone

Bifurcated lamination mandrels

Lamination pressure ovens

Boroscope and magnification camera system

AAA device team lead (covering) for straight and BIF ePTFE coverings

Created initial prototypes of illiac limb and bifurcated stent covering

Conducted detailed experimentation and product revision

Designed and built prototype and production tooling

Developed a repeatable process for illiac limbs with thin ePTFE

Organized the early stages of the ePTFE covering production, developed a production process flow design and plan for delivering 3 sizes of the product matrix, identified equipment and resources needed to deliver scaled production quantities

Supported yield improvements efforts for thin wall ePTFE stents

Precedent team ePTFE technical adviser – equipment, yield improvements and SPC

Ran process capability studies

Resolved contamination issues

Spearheaded transition into production

Redefined process limits

Bead adhesion task force with equipment and process upgrades –

Implemented process controls to reduce yarn melt fractures

Redesigned process to increase yields

Developed a pre-screening system for incoming raw materials

1990 - 1997 Meadox Medicals Inc., Oakland, New Jersey

Step & Taper Team and Lead (1995-97)

Positions held - Engineering Tech

Project lead with some engineering supervision - Prototyped, developed process, scaled and launched the shaped profile ePTFE vascular graft line for arterio-venus shunts and other peripheral use

Designed prototype radial expansion tooling and built the production version high pressure radial expansion to manufacture ePTFE shaped products.

Conducted detailed experimentation, analysis, and process and product revision reporting to engineering manager/technical supervisor

ePTFE Straight Graft Development Project (1991 – 1995)

Positions held - Engineering Tech, Lab Tech Assistant Lab Tech,

Key participant in technical team developing the ePTFE straight vascular graft process and product line

Acquired comprehensive knowledge of the following areas: ePTFE resin storage and blending, performing, extrusion, expansion, sintering, statistical process control, oven and tooling design.

Engaged in experimental design and interpretation of results, process and equipment trouble-shooting

Developed many prototype devices, one of which resulted in a US Patent viewed as a core platform technology for ePTFE covered stents.

Conceptualized and co-developed a multi-zone heated insert for a custom built high temperature and velocity oven which reduced the process chamber temperature gradient from ~100 F to ~3 F. This was a major technical stalling point of the program.

Concepualized a extruder die redesign to significantly improve the quality of the extruded product and minimize equipment disassembly. Product Quality and process reliability was greatly improved as a result.

New Equipment Technician for textile R&D equipment upgrades (1990-91)

Position held – Technician

Assembly, operational troubleshooting, and basic experimentation conducted on new yarn texturizer with equipment upgrades

Set up and qualification of TYT yarn tester, twisters, and cone winders

Acquired basic knowledge of textiles and related processing equipment

Education

Mercy College, Dobbs Ferry, New York (Manhattan Campus)

Bachelor of Science in Organizational Management (2001)

Bergen Community College, Paramus, New Jersey

Associates in Biology (1991 – 1995)

Certificates, Licenses and Other

24 US Patents to date related to Medical Devices

30 Patent publications under review

Over 100 inventions disclosed and IP related activities with Boston Scientific Patent Review Board and other

Six Sigma Green Belt

Multiple Financial articles published in Seeking Alpha

Personal Interests and Activities

Physical Fitness Activities:

Martial Arts

Running, Swimming and Biking

Weight Lifting

Financial

Currency Trading

Financial Strategy Modeling

Outdoors

Scuba Diving

Hiking

Aviation

Boating/ Kayaking

References Available upon request

Contact this candidate