Dawn Strahler, CQE, EIT

Summary:

Experience:

• Analyse and improve quality system documentation and company processes. Examples include engineering change orders (ECO), training, procedure and component specification formatting, manufacturing authorization, rework, and nonconforming material reports (NCMR), service and complaint handling.
  
• Perform Hazard Assessment, Failure Mode and Effect Analysis (FMEA), and risk management analysis for patient contact devices used in soft tissue coagulation for a variety of indications.
  
• Design, review, and perform design and process validations and verifications. Examples such as bond strength testing, cleaning steps, electrical integrity, and data programming of devices.
  
• Review and maintain Design History File (DHF) documentation for two multi-year projects. One product is on the market now in the US and EU, and one is in clinical trials in the US.
  
• Assist with FDA documentation to support 510(k) clearances and CE marks of systems including capital equipment, patient contact devices and accessories.
  
• Create, review, and approve Device Master Records (DMR) for patient contact device designs, including procedures and component specifications for product produced in a controlled evironment area (CEA), from component receipt and kitting, through lot manufacturing, packaging, sterilization, and release.
  
• 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) for products designed and manufactured within the company.
  
• Perform ongoing quality engineering activities on patient contact devices to improve device designs and manufacturing processes.
  
• Manage ethylene oxide (EtO) sterilization validations and product adoptions for four disposable products, including mixed and minimum/maximum loads.
  
• Complete shelf life studies using accelerated and real time aging techniques for product now on the market.
  
• Manage biocompatibility testing for limited duration mucosal membrane and indirect blood path contact devices.
  
• Design and develop balloon catheter sub-systems for product to treat Barrett's esophagus.
  
• Complete development activities for product marketing including packaging and labeling.
  
• Manage packaging validations and shipping validations of devices for shipment domestially and internationally in unit and shipper containers.
  
• Design and implement test and assembly fixtures and procedures for use in verifications testing and manufacturing.
  
• Perform training of employees, and supervise technicians.
  
• Coordinate Emergency Response Team.
  
• Coordinate company activities committee.
  
  

• 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:

Education and Professional Affiliations:

Curriculum Engineering Projects: