Director of Engineering
STI, EKF Diagnostics (formerly part of Thermo Fisher )
- Proposed business plans for new products, incorporating development times, validation requirements, sales projections and estimated payback period.
- Led effort in identifying and relocating our manufacturing facility to new locations. This included producing layouts, selecting property, installation of support systems, and overseeing build of facilities.
- Developed departmental budget including forecast for annual and monthly spends.
- Attended trade shows interfacing with customers and investigating competing technologies.
- Developed environmental control and PM procedures for all equipment used in building support and production.
- Led technical team in development of new desktop centrifuge for microbiology market. Designed verification studies for internal and clinical testing.
- Oversaw design control process for all products. Conformed to FDA, ISO, cGMP standards, participating fully in regulatory audits as lead technical manager.
- Managed staff of electrical engineers and technicians along with six contractors for various projects.
- Performed duties of Safety Coordinator, verifying all safety related procedures are followed, chemicals are documented with SDSs.
- Addressed all complaints (internal or external) and closed CAPAs with rigid root cause analysis.
- Developed processes for manufacturing, repair, and reprocessing of all equipment.
- Led process/product improvement team resulting in 10 percent annual material savings.
- Taking advantage of new FDA directives for mobile devices developed wireless dongle for existing products and integrated them with customers LIS systems.
- Lead on FMEA analysis for all engineering changes to existing products.
- Led redesign of acoustic transducer based micron measuring device for whole blood. This included complete reverse engineering of PCB and software to address obsolescence.
- Identified alternate polymers for housings to address product warranty issues (ESC cracking) while also accommodating over mold and dimensional requirements and minimizing tooling changes required.
- Led design effort to update UI and reduce footprint of VersaTREK Automated Microbial Detection System. Utilized thermal analysis to provide uniform incubation. This design achieved a $2.5M develop cost savings 12 month schedule improvement to the division.
- Performed all duties of traditional manufacturing/sustainability engineer including updating processes, tooling, work flow process, and layouts for added efficiency.
- Developed processes for manufacturing, repair, and reprocessing of all equipment.
- Led improvements/build of multiple vacuum formed and injection molding tools, metal spinning, and stamped tooling.