Engineer Development

WORK EXPERIENCE:

Boston Scientific

Maple Grove, MN

Senior Engineer - Process Development, Stent and Top Assembly:

June 2007-Current

. Top Assembly Core Team Member for Self-Expanding Stent Delivery

System.

- Led team through technology selections for 7 different

processes.

. Technologies include cold stent loading, diode laser

welding, and silicone lubricant coating

. Technology selection process was conducted with multiple

functions to account for risk to design, process, and

manufacturability.

. Recipient of new product development award for development

and implementation of cold loading system

- Developed schedule to coordinate process development

deliverables within overall project milestones.

. Team met or exceeded required dates for all deliverables

- Enhanced knowledge of multiple Boston Scientific systems

enabling efficient process and product design: Equipment, Design

Verification, Process Validation, Engineering Design Standards.

- Team piloted new Risk Management system driving team focus on

process impact to patient risk and development of appropriate

controls

- Drove development activities designed, executed, and analyzed by

cross-functional team

- Implemented in-process monitoring system on development line to

mitigate risk during Design Verification

- Led team of 12 engineers and technicians in process development

group

. Responsible for determining resource and skill need to

successfully complete project deliverables

- Actively participated in Technical Team meetings to ensure cross-

functional decisions are made regarding design and process,

including DCA resolution

- Managing capital allocation for Top Assembly for supporting

development through EU Launch builds, $3.2M

. Process Development resource responsible for Catheter salvage

processes. Responsibilities included construction and qualification

of fixtures; creating work instructions, process FMEA, updating ATMV

protocols and constructing reports.

. Functioned as Core Team Member for Peripheral Stent development

project and Catheter Top Assembly technology development.

- Led Stent Development team in constructing responsibility

matrix, creating the project schedule through design freeze.

- Successfully led team in completing Animal builds and Concept

Select deliverables.

- Constructed Technology Assessment for stent processing

- Led efforts for purchasing equipment needed for Top Assembly

Pilot line - $2M for numerous pieces of equipment.

- Formed development strategy for cold-loading stent technology

and leading technical resources

. Led $12M expansion at Plymouth Tech Center, more than doubling non-

commercial stent capacity

- Accountable for making technical decisions and completing all

activities for successful implementation and start-up of all

pilot processing equipment needed for PCA stents.

- Coordinated cross functional layout reviews for PTC expansion;

successfully providing needed space for each function affected

by expansion.

- Constructed and executed integration testing to ensure

capability of software system to run multiple chemical

processing lines, load stations, and unload stations, along with

accurately reporting all required input and outputs of the pilot

systems.

- Responsible for maintaining schedule to track equipment progress

and Process Development deliverables

- Process Development resource for all documentation required by

business systems used for equipment and software qualifications.

- Communicated status of project deliverable to multiple functions

and management levels.

. Supervisor for Engineering Technician in Stent Process Development

Group

- Identified development opportunities to enable promotion from

Technician III to Technician IV

- Developed skills specific to DoE design and analysis, equipment

requirements and installation, Measurement System Analysis

Process Engineer II - Stent Process Development:

March 2004-June 2007

. Completed DFSS and Six Sigma Training Modules.

- Measurement Systems Analysis applied through assessment of

various measurement tools used in stent processing.

- Mechanical DoE training used to construct, execute, and analyze

experiments focused on optimizing the stent etch and chemical

soak processes in the chemical wet lines.

. Process Development resource for cross-functional yield improvement

team, focusing on chemical processing of stents.

- Coordinated processing of experiments on pilot lines for team.

- Key technical resource for pilot processing and equipment used

- Constructed experiments to investigate chemical process

parameters - "out of the box" thinking.

. Process Development Resource for implementation and start-up of

chemical processing pilot line.

- Executed testing required to size power supplies needed for

processing line.

- PD resource responsible for all equipment validation

deliverables

- Constructed required documentation for processing product

through wet line and conducting operator and technician

training.

. Provided daily support to stent pilot processing staff - addressing

build issues, yield improvement activities, equipment improvements,

and preventative maintenance.

Innovex, Inc.

Maple Plain, MN

Process Engineer:

June 2001-2004

. Supervised daily quality and performance through copper etch

processing lines.

- Produced and updated the documentation pertaining to operating

the copper etch line: SOP, PCP, FMEA, SIPOC, Product Recipe,

Process Log, and Operator Checklists.

- Constructed and maintained worksheets tracking copper etch

process capacity and material usage; this incorporates material

type, time, initial quantity, and operator availability - SPC

charting.

- Performed capability studies to determine etching capability and

optimized operating parameters of the copper etch line.

Completed gage studies to determine if current systems were

acceptable to measure critical parameters.

- Continually investigated spray patterns, mechanical features,

and performance of etching line for identifying improvement

projects to the line and operating procedure.

. Completed Six Sigma training-applied training and learned tools by

leading and co-leading teams in company wide project competitions.

. Involved with new product introduction and implementation onto the

manufacturing floor.

. Gathered experience in several areas of producing flex circuits,

print, develop, coat resist, lay-up, lamination, etc.

EDUCATION:

St. Cloud State University - AACSB Accredited

MBA - Expected Graduation Date July 2012

South Dakota School of Mines and Technology, Rapid City, SD

B.S. in Chemical Engineering

Erin Hautala

Address: 17982 79th Ave. N. Cell

Phone: (763) 443 - 1147

Maple Grove, MN 55311

Home Phone: (763) 496 - 1880

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

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