Engineer Design

Eliot Zaiken

Email: *********@********.***

Address: Harvey Avenue

City: Atlanta

State: GA

Zip: 30016

Country: USA

Phone: 413-***-****

Skill Level: Management

Salary Range: $140,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

ELIOT ZAIKEN.CREATING STRATEGIC ADVANTAGES THROUGH INNOVATION & TEAM LEADERSHIP

*********@*****.***

Atlanta-GA

www.linkedin.com/in/eliotzaiken1

Results-driven Leader with a proven track record of successfully leading teams to drive innovative designs, concepts, successful introductions, & sustaining engineering efforts for medical devices. Demonstrated leadership skills with the ability to guide & motivate both direct reports & team members. Design Control and Quality System Proficiency with expertise in compliance, remediation activities, and assembling/auditing Design History Files. Relationship Manager guiding health care professionals/stakeholders in understanding/defining customer requirements; adept in presenting concepts and strategies to senior management. Extensive VOC/Market Research experience in identifying and evaluating user front end requirements and validating user preferences. Creative Innovator with 20+ years experience in product development for disposable, mechanical, & electromechanical devices - patents pending.

CORE COMPETENCIES THAT OPTIMIZE PERFORMANCE

Program/Project Management: Over 13 years of direct project management (Core Team Leader) leading national and international multi-discipline teams focused on the development of new medical devices & line extensions with extended teams/manufacturing sites located in USA, Germany, Mexico, Ireland, Canada, Costa Rica, and Malaysia

Extensive knowledge in Medical Device Product Development: Extensive experience (20+ years) in product development from concept to commercialization of Class I - III disposable, reusable, & implantable devices using Phase Gate methodology

Quality Engineering/Design Assurance: Proficient with Quality Systems, Compliance, Complaints, and Design Controls including Design Verification & Validation, Risk Management, and Process Qualification activities ensuring compliance with 21 CFR Part 820 (QSR), ISO 13485, IEC 60601-1, IEC 60601-2, IEC 62304, and IEC 60825-1

New Concept Development - Demonstrated ability in clarifying and classifying market/product needs, creative and innovative design/problem solving, iterative design process, and establishing development plans

Extensive product knowledge in a variety of product lines including Urological Catheters, Syringes and Pen Needles, Vascular and Obstetric catheters, Ex-Vivo Blood Flow Technology, & Blood Pressure Monitoring devices

Hands-On Design Experience: Comprehensive design experience involving injection molding, extrusion, adhesives, ultrasonic welding, snap-fit design, fluid delivery systems, and material selection.

Molded Part Design: Broad experience in the design and manufacture of molded parts including Polypropylene, Polycarbonate, Polyethylene, and other engineering materials

Budgeting and Scheduling: Proficiency at estimating and maintaining product development costs (unit cost, expense, and capital) and developing accurate scheduling with resource allocations

Engineering Management: Over seven years of direct supervision of development & design engineers

Assembly Methodology: Broad knowledge & experience in high (600 ppm) and low volume assembly with automated, semi-automated, and manual processes. Ramp-up strategy planning

Process Validation: Proficient in capital equipment and process validations (IQ/OQ/PQ) including DOE and Statistical Analysis (Cpk, Ppk) for manual, semi-manual, and high volume equipment.

Quality Systems: Proficiency in establishing/conducting Risk Management, FMEA, Audits, Verification & Validation

Six Sigma Training - Green Belt trained: Experienced using statistical tools (MINITAB) including surface response curves, hypothesis testing, and sample size determination

Software Verification & Validation: Experience in methodology and execution of medical device software V&V

Presentation Skills: Skilled at preparing and making presentations ranging from project updates, business opportunities, and technical/design reviews

Interpersonal Communication: Effective communicator - Comfortable speaking and in a wide variety of situations including with physicians and health care professionals, technical staff, and management

Strategic Business Strategies: Experienced in evaluating and assessing Business Opportunities, preparing Business Plans, Income Statements, and making presentations & recommendations to upper management

VOC and Market Research: Extensive VOC and market Research experience including one-on-one interviews, focus groups, and development of affinity diagrams to identifying customer requirements and test/validate product preference

Intellectual Property Strategy: Thorough understanding of Intellectual Property filing and strategy

3-D Modeling: Experienced with 3-D Modeling (Solidworks and Pro-Engineer), SLA technology, & rapid prototyping

Regulatory Requirements: Understanding of FDA and CE Regulatory requirement submissions

DRIVING RESULTS WITH VISIONARY LEADERSHIP AND CONSISTENT EXECUTION

Program Manager Contract Consultant, Hospira, Lake Forest, IL

August 2012 - January 2013

Leading development teams in the remediation of quality performance issues with IV Tubing sets. Included establishing project focus, oversight of functional team members, participation in market research, and schedule/budget management.

Quality Engineer-Design Assurance Contract Consultant, Angiodynamics, Marlborough, MA

April -August 2012

Preparing and reviewing protocols, reports, and Design History Files for compliance to ISO and FDA requirement for laser ablation products/catheters for minimally invasive treatments of cancer and peripheral vascular disease. Reviewed/proposed methodologies for adherence to Software Verification and Validation.

Senior Program Manager, CR Bard, Covington, GA - Bard Medical Division

2010 to 2012

New product development/project leadership for urethral catheters and urology devices; Senior member of technical staff responsible for mentoring R&D engineers

Direct Leadership, responsibility, and management of international cross-functional core teams developing disposable urological catheters: Development Budget $0.5MM, Capital Investment $5MM for manufacturing Capacity 10MM+ units/year, Extended Team over 16 FTE, Cumulative sales revenue $30MM projected for first three years post launch.

Successfully assumed leadership of new catheter project team resolving team dynamic issues; development of detailed project schedule, monthly budgets, and adherence to new in-house product design transfer requirements.

Development of Completed Concept Phase plan for new urethral catheter: Lead role in planning/implementing VOC/Market Research interviews to develop/validate product requirements (Sessions in US and EU). Development of innovative design concepts for urethral catheters and prototype development leading to multiple patent submissions.

Successfully led team to transfer of capital equipment to offshore manufacturing facilities

Lead contributor to Voiding Franchise for new product/sustaining engineering product strategy

Mentoring/training of R&D engineers in design controls, statistical techniques, technical/design reviews, risk management, verification and validation activities, and FMEA.

Staff Engineer, Becton Dickinson, Franklin Lakes, NJ - Diabetes Care 2006 to 2010 New product development/Project Leadership for drug delivery devices; Senior member of technical staff responsible for mentoring R&D engineers

Direct Leadership, responsibility, and management of international cross-functional core teams developing disposable drug delivery devices: Development Budget $4MM, Capital Investment $40MM for manufacturing Capacity > 50MM units/year, Extended Team over 16 FTE, Annual revenues of over $20MM projected for first two years post launch.

Development of innovative designs for drug delivery devices leading to multiple patent submissions (patents pending).

Lead role in planning/implementing VOC/Market Research interviews to develop/validate product requirements

Responsible for the development and maintenance of project budgets (capital and expense) and schedule

Lead role in assessing device business opportunities with external pharmaceutical partners

Direct management and supervision of one development engineer and one designer

Diabetes Care Intellectual Property Review Board Facilitator; Active participant in IP Business Strategy.

Mentoring/training of R&D engineers in design controls, statistical techniques, and verification/validation activities

Principal Engineer, Covidien, Ludlow, MA - Kendall: Neonatal & Obstetrics R&D 2003 to 2006

Core Team Leader for the Development and Implementation of Sterile Disposable Invasive Class II Obstetric Devices to be used during Labor and Delivery with a Focus on Intrauterine Pressure Catheters, Umbilical Vessel Catheters, Peripherally Inserted Central Catheters, and Fetal Scalp Electrode Catheters

Direct Leadership, responsibility, and management of multiple simultaneous cross-functional development teams to implement new products, line extensions, and cost reductions for a $50M product line. Development Budget $1MM, Capital Investment $2MM for manufacturing Capacity > 500K units/year, Extended Team over 12 FTE, Annual revenues of over $5MM projected for first two years post launch.

Innovative design of disposable obstetric catheter devices and reusable cabling system (patent pending) to interface with Intrauterine Pressure catheters - $5M yearly sales volume

Development/ maintenance of all design related documentation: Risk Analyses, DFMEA, Design Inputs, and V&V

Lead role in assessing value and feasibility of new proposed Obstetric Devices

Sr. Project Engineer: Welch Allyn, Inc., Arden, NC - Vital Signs R&D 1998 - 2003

Oversight and Responsibility of all Product Development in the Core Blood Pressure line for Class I and Class II Non-Sterile Non-Invasive Monitoring including Sphygmomanometers, Mercurial gages, and Stethoscopes ($25M product line)

Direct leadership, responsibility, & management of multiple simultaneous cross-functional teams to implement new products, line extensions, & cost reductions - 85% Mechanical, 15% Electro-Mechanical

Lead role in all product development for mechanical blood pressure monitoring. Strategic planning, scheduling, project/fiscal budget preparation, and management/preparation of product design and development documentation

Management/supervision of technicians/engineers and external designers/consultants

Design and introduction of an electronic stethoscope with software to record phonocardiogram -Worked closely with cardiologists to evaluate and develop software to assess heart sounds from Phonocardiogram

COBE Laboratories (now Terumo BCT)

1989 - 1991

Project Engineer/Clinical Monitor: Blood Component Therapy R&D

Design, Development, and Technical support for the clinical performance of the Trima Class II and III Blood Flow Separation Product

Design of sterile high volume disposable injection molded components for blood flow separation

Design of a flow restrictor for fluid delivery systems

Validation of electro-mechanical systems (pumps and sensors) that interface with disposable components

Lead role in coordinating & performing clinical monitoring at international Sites (Western Europe)

Clinical data analyses of white cell contamination and hemolysis of collected components

Development of clinical protocols & clinical database management

Additional Relevant Work History

Engineering/Quality Assurance Consultant: Denver, CO

Performed QA audits and evaluations for several biomedical component Manufacturers' in Good Manufacturing Practices (GMP), Statistical Process Control (SPC), and FDA regulatory document submissions

Performed on-site QA audits for biomedical component manufacturers including evaluation of adherence to FDA requirements, training in Statistical Process Control, recommendations for documentation systems and mfg. methods

Biomedical Engineer: COBE Lab., Lakewood, CO - Blood Component Therapy R&D

Research, design, development, & technical support from a systems approach for multiple aspects of Class II and III Blood Flow Separation technology from pre-introduction to FDA approval for the Spectra Product Line. Direct Responsibility for the Design & Validation of multiple components of the Sterile Disposable Tubing Set

Design of sterile high volume disposable plastic injection molded and extruded components for both ETO and Gamma sterilization; design and validation of peristaltic pump blood delivery systems and software algorithms for blood flow separation procedures; specification of manufacturing procedures; clinical monitoring; development of clinical protocols; liaison with field service to resolve technical issues

R&D Project Engineer: Shiley, Inc, Irvine, CA - Cardiovascular Division

Design, develop, and introduce Class III Sterile implantable Mechanical Heart Valve Prostheses focusing on the Bjork-Shiley Monostrut Heart Valve. Technical Support for existing products

Mechanical design of implantable mechanical heart valves, design of inspection methodology using a scanning electron microscope, preparation of IDE and PMA FDA regulatory submissions, fatigue, fracture, and stress analyses; design & execution of in-vitro experiments, supervision of one designer

EDUCATION

B.S.Eng. M. University of Illinois - Champaign/Urbana; Bachelors of Science in Engineering Mechanics - Focus on Mechanical behavior of materials. Undergraduate Research Project: "Repeated Strain-Aging of High Carbon Steel"

M.E.M.E. University of California - Berkeley; Master's of Engineering in Mechanical Engineering - Focus on Fracture Mechanics, Mechanical Metallurgy, and Business Administration. Master's project: "Near-Threshold Fatigue Crack Propagation Behavior of Aluminum Alloys"

PATENT APPLICATIONS

* 8,109,883 "Cable monitoring apparatus" Granted Feb-2012

* WO2009102596 "Safety Needle Assembly", Filed Feb-2009

* WO2009154826 "Safety Pen Needle Assembly Having Shield for Non-Patient End", Filed March-2009

* WO2009114762 "Safety Pen Needle Assembly w/ Shielding for Patient & Non-Patient Ends", Filed March-2009

* US20110118667 "Hub Assembly Having A Hidden Needle For A Drug Delivery Pen, Filed May-2011

* US20080177168 "ECG Lead Wire Organizer and Dispenser", Dec-2007

* US20080082024 "Signal replication medical apparatus", Sept-2006

* US20060073728 "Intrauterine Pressure Catheter Interface Cabling System", Filed April-2006

HOBBIES

Extensive International & Domestic Travel Experience,

Twenty years experience as a Ballroom Dance Instructor,

Home Improvement & Automotive Repair

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