David Osterhoudt Email & Phone Number

Rochester, NY, US

Rochester, New York Area

• Responsible for reliability and cost of DRX-1 digital X-ray imaging systems, proactive collection and interpretation of data for identifying trends, and driving product and service process improvements.
• Completed business cases for new designs, based on statistical analysis of historical and projected failure rates.
• Managed failure analysis and repair of digital imagers returned from the field.
• Use of field data to drive corrective action and product improvements.
• Provided statistical reliability analyses of factors and design changes.
• Provided technical support for Field Engineers and customers.

• Served as Quality Engineer, Program Assurance Manager, and Reliability & Risk Engineer on high reliability space based imaging systems.
• Ensured a $2M incentive fee was received by performing measurement system analysis and verifying product acceptability prior to a key customer audit.
• Led cross-functional teams in Root Cause and Corrective Action activities. Assigned tasks and managed closure for on-time product deliveries.
• Performed Failure Mode Effects and Criticality Analyses (FMEA, FMECA) to uncover single point failures. Presented results at design reviews.
• Ensured compliance with in-house Quality System and customer requirements during manufacturing and testing. Worked directly with customer on quality issues.
• Facilitated Risk Management activities and retired $4M worth of risks.

• Led quality and reliability improvements using Six Sigma methodologies for new and existing products and processes.
• Consulted in Design for Six Sigma for no-surprise product and process launches.
• Designed and analyzed many statistical experiments (DOE), process capability studies, and Gage R&Rs that led to quality improvements and reduced cost.
• Led team of engineers that achieved 98% reduction of defects, reduction of cycle time by 1 day, and $212K annual savings for K-Pro digital cameras.
• Performed design simulation on complex optical system using measured process covariances. Identified the largest contributor to a low light problem, and eliminated the need for a wasteful adjustment feature in the field.
• Served on several projects, sometimes simultaneously, including Kodak Perfect Touch, professional digital cameras, and single-use cameras.

• Provided electrical support for manufacturing and quality of X-ray film processors and Computed Radiography systems.
• Managed safety and regulatory compliance (UL, CSA, TUV). Obtained the CE mark for Safety and EMC directives on all X-Omat processors well before the 1996 deadline.
• Performed root cause analyses on field returns for Medical Device Reporting. Avoided an unnecessary market withdrawal with one such analysis.
• Eliminated a circuit board problem that caused a 68% failure rate for image artifacts.
• Ensured compliance with FDA and ISO 9000 regulations.
• Provided support for field service operations.

• Managed all aspects of quality and FDA compliance on advanced electronic medical devices.
• Developed quality plans for purchased parts and trained inspectors. Evaluated supplier capabilities, performed supplier audits and ship-to-stock certifications.
• Submitted 510(K) notifications and obtained approval from FDA on new products.
• Developed and implemented a Software Quality Assurance program.
• Led corrective action teams on quality issues.
• Led FMEA, design reviews, and capability studies during product development.

• Designed analog and digital based electronics for Automated Test Equipment used for testing aircraft wiring harnesses and instrumentation systems.
• Worked with microprocessors (68000, 8080 / 8085, MCS48), Analog-Digital and Digital-Analog converters, PALs, timers, instrumentation amps, and memory devices. Used Mentor Graphics Schematic Capture for circuit design.

• Ensured quality of RF Electronic Countermeasures equipment. Supported customer during audits.
• Performed quality audits in-house and at suppliers.

M.S., Matematical And Applied Statistics

Activities and Societies: Honor Society of Phi Kappa PhiConcentrations: Industrial Statistics, Theory

B.S., Electrical Engineering Technology