Engineer Project Manager

ELLA ZASLAVSKY ****.*********@*****.***

** ****** ******, **********, ** 01945 781-***-****

Summary of qualifications:

Innovative R&D and Manufacturing Implementation Engineer with over 20 years of experience in medical

product development field.

Nine granted US Patents and four pending US Patent Applications.

Multi-disciplinary experience as a coordinator and contributor of development programs for a variety of medical

devices: single-use Bone Biopsy Needle for navigated minimally invasive surgery (MIS), cytology brush

catheter and endoscopic multiple ligating device, implantable titanium soft tissue anchors, non-magnetic

reusable pedicle screw drivers, a disposable device to be used with Ventricular Assist Device (VAD) and more.

Regulatory experience with 510K submissions and CE Mark approvals.

Skills:

Entrepreneurial, self-starter, team builder in a cross-functional environment.

Mentor to new and less experienced technical personnel.

Extensive knowledge of engineering materials and processes.

Practical knowledge of GMPs and Design for Manufacturability.

Experience in compiling specifications and test methodologies: verification and validation testing.

RABQSA certified as Internal Auditor in FDA Medical Device QSR, ISO 9000/13485.

Design Controls expertise. Good organization, documentation and communication skills.

Solid Works (including Finite Element Analysis), Pro-E, DOORS, MS Word/Excel/PowerPoint/Project.

Major Achievements:

Saved about $1M per year while in device development and transferring components process of newly

acquired Extremities MRI (magnetic resonance imaging) System to GE approved vendors.

Took new disposable Bone Biopsy Needle for navigated minimally invasive surgery from the concept to

successful release to manufacturing.

W orked with surgeons to identify and reduce the number of steps for installation of VAD.

Developed and implemented a disposable self-tapping, self-drilling soft tissue repair system.

Significantly reduced production costs by using the same molding tool and developing a reliable ultrasonic

welding process for both ABS and Vectra parts using the same welding nest.

Established and maintained close collaborations with external customers, such as Boston Scientific, Pfizer,

Johnson & Johnson, etc.

Designed, developed and implemented a life-saving endoscopic multiple ligating device.

Experience:

GE HEALTHCARE 2003-present

Senior Mechanical Engineer/ Product Engineer

R&D, Specialty MR, Wilmington, MA 2010-present

Instrumental in coordinating affords of a multi-functional team that is in process of establishing newly acquired

Extremities MRI (magnetic resonance imaging) System under GE quality system.

Actively involved in device development process and cost reduction efforts while transferring to GE approved

vendors. Saved about $1M per year.

Made sure that all transferred components are RoHS compliant.

Designed and implemented an Automated Gradient Coil Alignment test fixture using SolidWorks.

W as part of a team effort to design and build Neonate MR Suite at the Boston Children’s Hospital.

R&D, Navigation & Visualization Technology, Lawrence, MA 2003-2010

As a Project Lead of Spine and Orthopedic tools designed for use with Image Guided Surgery

Took new disposable Bone Biopsy Needle for MIS from concept though design utilizing SolidWorks to a successful

market release.

Participated in a team effort to analyze and resolve compatibility problem when new molded Receiver was

released. Was part of a design team to create a cost effective solution.

Participated in process of design streamlining of all new pedicle screw Extenders used in navigated MIS by

applying Design for Manufacturability and Design for Assembly techniques. Led Verification and Validation

testing and supervised the documentation updates.

Analyzed navigation system’s menu and surgical procedure with Spine Handle tools. Identified a potential

problem for newly released Screw Extenders. Participated in CAPA.

W orked closely with Regulatory department in writing a 510(k)s.

During FDA consent decree remediation m entored ME group in coordinating product re-verification activities

per newly established Quality Management System using DOORS traceability tool.

ABIOMED, Inc., Danvers, MA 1998-2003

R&D, Senior Mechanical Engineer/ Product Manager

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ELLA ZASLAVSKY ****.*********@*****.***

15 Harbor Avenue, Marblehead, MA 01945 781-***-****

As a member of a new VAD “fast track” design group

W orked with surgeons in identifying all accessories in order to minimize VAD installation steps.

Designed and implemented an extension device to be used with VAD and existing cannulae using SolidWorks.

As a member of AbioCor™ a Fully Implantable Replacement Heart development team

Analyzed flexing cycle and resistance of Implantable Interconnecting Harness, proposed and implemented a

new alloy (current conductor) to be used for further testing with AbioCor™.

Designed, validated and implemented sterile packaging for all Implantable Components.

Timely responded to the first at-home AbioCor™ recipient’s request for a “flexible” implantable Transcutaneous

Energy Transmission Coil by changing the geometry of the coil and materials.

Devised a method of handling lithium-ion batteries per Hazardous Material Regulations.

Participated in animal studies for complete system functionality as well as human -fit studies.

As a Research Group member of government-supported programs (NIH)

Designed and built working prototypes of Laparoscopic Articulating Tissue Pick, Organ Elevation Device,

Ligating/Suturing Instrument, Tissue Double Grasper and Tubal Anastomosis Catheter.

Wright Medical Technology, Inc., Questus Arthroscopy, Marblehead, MA 1995-1998

R&D, Senior Project Engineer

As a Team Leader responsible for design and implementation of new MIS instruments .

Contributed to a proposal that described a new way of ACL (anterior cruciate ligament) repair kit: two-part

harvesting saw, graft preparation table, femoral and tibia tunnel drilling calibrated adjustable reamer, eccentric

bushing, fixators, tensiometer and fixating key. The proposal was approved for further development and

commercialization.

Took a concept of disposable self-tapping, self-drilling soft tissue repair system through design, with use of

such materials as titanium, stainless steel, ABS, silicone, etc. into manufacturing.

W orked with marketing group on a line extension for soft tissue repair system, such as a set of reusable

drivers and an anchor with pre-loaded wire leader for suture threading.

Collaborated with molding company at the early design stage and saved resources by use of a single molding

tool for both ABS disposable and Liquid Crystal Polymer Vectra™ reusable parts.

W orked closely with production team on developing a reliable ultrasonic welding process for both ABS and

Vectra parts using the same welding nest.

As a member of the management team was responsible for Design Control activities in order to attain the CE Mark

for all Questus Arthroscopy products.

ACT Medical, Inc., (a contract design, development and manufacturing company), Waltham, MA 1992-1998

R&D, Product Research and Development Engineer/ Project Manager

As a part of a small innovative group worked closely with customers, such as Boston Scientific, Pfizer, Johnson &

Johnson, etc.

Helped to turn ideas into cost effective, ergonomic designs and completed their transition into manufacturing

by using GMP’s and incorporating a variety of processes, including injection and insert molding, silicone

compression molding, metal stamping and machining, spot welding, RF induction heating, Ultrasonic welding

and swaging.

Supported QA and regulatory departments.

As a Team Leader conceived and implemented a novel idea of endoscopic multiple ligating device-catheter.

Cooperated with marketing by addressing specif ic design limitation.

Developed new material (synthetic rubber) with unique properties using variety of resources.

As a Project Leader responsible for release of endoscopic single use double lumen cytology brush catheter

W orked closely with a vendor to develop a process for manufacturing special double lumen tubing that is

compatible with .035” guidewire and 3mm cytology brush.

Developed a color-coded distal end scheme to facilitate depth verification and stricture measurements

St. Jude Medical, Inc., Cardiac Assist Division, Chelmsford, MA 1989-1992

R&D, Senior Designer

As a team member was responsible for design and development of a new Intra -Aortic Balloon Pump (IABP).

BS in Mechanical Engineering, Polytechnic Institute, Lvov, Ukraine

Education:

MS in Patent Practice, Patent Institute, Moscow, Russia

GE Project Management best practices

References Furnished Upon Request

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