Manager Mechanical

Melanie Schneider

abjv4j@r.postjobfree.com ( 949-***-****

MEDICAL PRODUCT DEVELOPMENT ENGINEERING DOCUMENTATION SPECIALIST

Successful medical product development documentation specialist with a

broad array of expertise in technical engineering design, graphic design,

labeling, and configuration management of electro-mechanical high tech

products; Managed a R&D design services team and prioritized workflow for

multiple projects; Trained employees and contractors on proper industry

standard documentation practices for printed circuit board and mechanical

technical data packages, and Engineering Change Order procedures.

AREAS OF EXPERTISE

. Electro-Mechanical designs and documentation (using SolidWorks,

ProEngineer and CAM 350 CAD software) for PCBs, machined, cast,

molded, and sheet metal parts and product subassemblies per ANSI/ASME

design standards

. Technical writing including operator's and service manuals, IFUs,

standard operating and work procedures, technical protocols and

reports (using FrameMaker and Microsoft Word)

. Labeling and graphic design (using Corel Draw and Adobe Illustrator

software) and labeling language translation coordinator for

distribution to European sites in compliance with EN 980:2008; ISO

15223-1:2007; ISO 780:1997; ISO 7010; and Medical Device Directive

(MDD) regulations

. Document control and configuration management; Certified

International Configuration Manager (C.I.C.M.)

Key Skills (Quick to master new software packages)

SoildWorks (8 yrs.) PDMWorks (5 yrs.) ProEngineer (3 yrs.)

Anvil 1000 Adobe FrameMaker Adobe Acrobat Professional &

Distiller

Corel Draw Corel Photo Paint CAM 350

JD Edwards MRP Microsoft Office Suite Bar Tender

PROFESSIONAL EXPERIENCE

(Ultimate Staffing Services contractor) Edwards Lifesciences LLC -

Irvine, California 2009 - present

Labeling Specialist

Responsible for the development of activities related to labeling and

documentation working independently and within project teams to complete

projects focused on the development and processing of labeling. Manage

label documentation strategies, LCR and ECR packages, information audit,

information verification, problem resolution, and coordination of

ancillary teams and facilitates communications to both on and off-shore

teams as related to labeling.

Terumo Cardiovascular Systems Corporation - Tustin, California 1990

- 2009

Terumo is a world wide medical company with over 12,000 employees and

over $2.9 billion in yearly sales (www.terumo.com)

Product Development Design Specialist (2006-2009)

As part of the New Product Development (R&D) Group played integral roles in

the supervision and development of the CDI 1000 Multi-Modal Monitoring

System and Neurovascular Monitoring (NVM) System product lines.

. Provided supervision to contract employees (2 mechanical design

engineers, 1 technical writer)

. Managed Product Development's Design Services project workflow

. Performed complete document change order (DCO), drawing & document

checks for accuracy and completeness in accordance with Company's

Quality System's requirements and procedures

. Developed and generated mechanical and electronic designs and

documentation

. Designed all the product labeling and procured initial orders used on

or with the product; created the product disposable Instructions for

Use (IFU) and designed the graphics for the monitor's Graphic User

Interface (GUI)

. Editorial manager of 2 operator's manuals

. Coordinated language translations in 11 languages of the products'

operator manuals, IFU, product labeling and software GUI with the

company's translation service bureau

. Created master BOMs for Material Report Processing and

Configuration Management systems

. Managed and developed designs for the product packaging which

included box cartons, insert foam materials, etc.

Terumo Cardiovascular Systems Corporation (continued)

Project Specialist II (2000-2005)

Project work completed in this role included the CDI 101 Hematocrit/Oxygen

Saturation Monitoring System and the Khuri Myocardial pH Monitoring System

product lines.

. Managed the work of 2 contract designers assigned to the project

. Created the monitor and interface module assembly, subassembly and

detail mechanical drawings

. Created all the PCB documentation packages

. Created the master BOM for Material Report Processing and

Configuration Management systems

. Authored the product operator's manual and created the graphics

. Created product labeling and wrote technical verification protocols

reports for the labeling

. Provided design documentation support for both monitoring systems

. Completed CDI 101 project in record time of 1 year (Company

average time is 3 years)

Advanced Product Designer (1998-1999)

Provided design and documentation support for the R&D Group for the CDI 500

Blood Parameter Monitoring System used during cardiopulmonary bypass

surgery.

. Created documentation packages for large assemblies, detailed plastic

& sheet metal fabricated parts, cable assemblies, and tool / fixtures

. Developed the company documentation procedure for printed circuit

boards

. Created the documentation packages for printed circuit boards

. Provided Marketing with design graphics used in the marketing

literature and the Operator's Manual

. Authored the CDI 500 Service Manual using FrameMaker software and

created an interactive user friendly PDF version using Adobe Acrobat

Professional for field service use

Product Designer (1990-1997)

Research & Development - Blood Gas Monitors

Hughes Aircraft Company, Irvine, CA (1982-1989)

Electro-Mechanical Drafter, Microelectronics Division

Created electro-mechanical detail part and assembly drawings and schematic

diagrams; Designed printed circuit board (PCB) layouts and created PCB

documentations packages

Scientific Systems Laboratories, Anaheim, CA (1980-1982)

Electronics Drafter/Designer

Designed microelectronic hybrid circuits (modems and DTMF receivers) in the

telecommunications industry

Portfolio available upon request

EDUCATION

Golden West College, Huntington Beach, CA

Course studies in Liberal Arts

Orange Coast College, Costa Mesa, CA

Courses in Electronics, CNC Machining, Mathematics, Product Illustration,

Computer graphics

California College of Technology, Anaheim, CA

Associates of Arts, Electro-Mechanical Design

PROFESSIONAL TRAINING

Certified International Configuration Manager (C.I.C.M.)

SolidWorks Essentials, Advanced, Sheet Metal & Weldments (certificates)

Design Control, the FDA and ISO (certificate)

Geometric & Dimensional Tolerancing (certificate)

CNC Machining and Programming (certificate)

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