Manager of Engineering
Medical Device Manufacturing Industry
Responsible for all Engineering Operations within the Dover, NH manufacturing facility. This also includes providing technical support for our corporate headquarters in Montgomeryville, PA.
- Engineering Operations
- Quoting and New Product Development
- New Device R & D
- Manufacturing Process Engineering
Notable accomplishments include:
- Protocol and Validation System: A prime opportunity recognized early in my tenure as an Engineering Manager, was to establish an organized protocol system for documenting validations. Answering to this challenge, a protocol system was developed and successfully implemented. This system has remained in place and continues to grow.
- Quote Tracking System: Project delegated under a “Goal Incentive” platform. Designed program to provide key quoting metrics such as scheduling, turnover, purchase order to quote ratio. System provided key outputs for dashboard performance metrics.
- Business Systems Migration: Project team member of a multi-facility migration and consolidation to a common business system software (MAS 200). Project was completed within budget and systems went on line within the timeframe scheduled. Successful migration to the new system has been realized. All business, within 3 facilities, are on line and operating successfully
- Re-Validation of EtO Sterization process : Providing support to Quality Control during a time of a streamlined staff base, my task was to manage the entire Sterilization Revalidation project. This include, writing protocols, designing logistics and combining efforts between the sterilization facility and the testing laboratory. Created physical mock-up loads to simulate “worse-case” densities. Researched and determined a master validation load that best represented a vast product line of possibilities. Conducted sub-lethal, half and full cycle to a sterility level of 10-6. Scope of testing also included evaluating EtO residual burn- off in accordance with applicable ANSI standards.