Dawn Strahler, CQE, EIT

e-mail: Dawn(dot)Strahler(at)swe(dot)org
homepage: http://www.alpinebutterfly.org/~dawn

Summary:

Engineering professional with over ten years of experience in the medical device and biotechnology industries. Expertise in project and process execution of quality systems and device development. Strengths include development of innovative solutions, application of engineering principles to scientific problems, interaction with technical teams, and expertise in quality and business practices.

Experience:

Stellartech Research Corp., Sunnyvale, CA
Mechanical R&D Engineer, 2003 to 2005, Quality Engineer, 2005 to 2009 (Senior, 2006 on), Sr. Quality Systems Engineer, 2009 to present
Analyse and improve quality system documentation and company processes.
Perform Hazard Assessment, Failure Mode and Effect Analysis (FMEA), and risk management analysis.
Design, review, and perform design and process validations and verifications.
Review and maintain Design History File (DHF) documentation.
Assist with FDA documentation to support approvals.
Create, review, and approve Device Master Records (DMR) for patient contact device designs, including procedures and component specifications.
Review and approve Device History Records (DHR) for patient contact finished device release.
Coordinate and perform field complaint investigations and Corrective and Preventative Actions (CAPA).
Perform ongoing quality engineering activities on patient contact devices to improve device designs and manufacturing processes.
Manage sterilization validations, packaging validations, and shipping validations.
Design and develop catheter sub-systems.
Complete development activities for product marketing including packaging and labeling.
Design and implement test and assembly fixtures and procedures.
Perform training of employees, and supervise technicians.
Coordinate Emergency Response Team.
Coordinate company activities committee.

Hyseq Pharmaceuticals, Inc., Sunnyvale, CA
Biopharmaceutical Engineer/ Robotics Integrator, 1998 to 2002
Developed and implemented high precision large gantry robotics systems for use in laboratory automation of genomic research with engineering team. Functions performed by systems include clone replication, PCR inoculation, DNA spotting, hybridization, and clone retrieval.
Programmed robotic equipment in Java to perform these duties and interface with company SQL databases for record keeping and cross-checking.
Interfaced with scientists for desired systems and worked with users throughout the design process to ensure all requirements met.
Integrated new devices into production line and configured system to meet laboratory needs.
Maintained production systems for maximum functionality and minimal down-time. Responded promptly to all problems reported, and performed troubleshooting to prevent and detect problems in the future.
Upgraded systems to be more efficient, precise, user-friendly, and custom-fit for high throughput production line.
Wrote documentation and Standard Operating Procedures (SOPs) for equipment and processes.
Machined and assembled prototypes for upgrades and new robotic tooling and platforms.
Performed cost analysis and purchased supplies for department needs.
Implemented Computerized Maintenance Management Software (CMMS).
Designed and maintained departmental Intranet site using Hypertext Markup Language (HTML).

Temporary and Part Time Experience:

Planet Granite, Santa Clara and Sunnyvale, CA
Instructor/Supervisor, 2002 to present
Teach beginning and technique lessons, register customers, run kids parties, facilitate sales, schedule staff tasks.

Debbie Lyn's Costumes, Sunnyvale, CA
Seasonal Associate, 2002
Helped customers find costumes, get ideas.

Du-All Safety and Precision, Fremont, CA
Temporary Administrative Assistant, 1998
Performed reception duties, updated website, assisted with class preparations.

Silicon Light Machines, Sunnyvale, CA
Contract Consultant, 1998
Created Visual Basic Graphical User Interfaces (GUIs) and Visual C++ software.

University of California Santa Barbara, BioMaterials Engineering
Summer Research Assistant, 1996 and 1997
Conducted research related to morphological changes in sustained release drug delivery system using Transmission Electron Microscope (TEM). Researched formulations of hydrogels. Constructed lyophilization apparatus.

Lasers By Fifi, Claremont, CA
Business Manager, 1995 to 1997
Maintained all records and budget for small business using computer system. Scheduled and planned operations.

Education and Professional Affiliations:

Bachelor of Science in Engineering, Harvey Mudd College, Claremont, CA
ASQ Certified Quality Engineer 50283
Engineer-In-Training XE106099
ABC Bartending School, San Leandro, CA
Society of Women Engineers, Member
American Society for Quality, Member

Curriculum Engineering Projects:

Irvine Ranch Water District,Irvine, CA
Team Leader, 1997 to 1998
Managed five person team developing and implementing customer oriented Internet presence via series of consistently designed web pages.

IsoStent Inc., San Carlos, CA
Spring Team Member. 1997
Designed heating and fluid flow system in accelerated fatigue test system for coronary artery stents with team of four.

Dunlap Elementary School, Yucaipa, CA
Team Member, 1995
Designed and specified playground to meet current safety regulations with team of five. Constructed parts of final design prototype. Prepared sections of final report.

6/09