Manager of Manufacturing Engineering team responsible for optimizing quality and throughput of entire process of rapid diagnostic tests. Individual contributor responsible for ensuring robust quality of manufacturing operations and improving NPI’s of rapid diagnostic tests.

Responsible for design control and risk management for next generation pacemakerImplementing compliance to CFR 21 Part 4 to comply with requirements for combination products.-Revamped design control process to ensure product safety and efficacy met critical customer requirements and necessary clinical outcomes for a Class 3 cardiac pacemaker-Authored design control for critical subsystem of Class 3 combination product; including but not limited to user needs, design inputs, design outputs, DFMEA, and Risk Management Plan-Saved > $600k of scrap cost associated with distressed inventory through coordinating sales, marketing, operations and quality to extend shelf life of product on market-Remediated risk management files upon completion of gap analysis of Design V&V and process validation testing-Implemented system coordinating marketing, sales, operations, and quality to extend the shelf life of > $600k of distressed inventory and reduce capacity demand by 20%-Automated communication and tracking during audits via complex macros to facilitate timely communication between front room, back room, and subject matter experts through implementation of macros via MS SharePoint and MS Excel-Managed successful design verification testing with contracted testing suppliers for critical subsystem of Class 3 cardiac pacemaker; including product performance, packaging integrity, and API stability-Guided team in successful implementation of CAPA, to address design controls inadequately incorporating pharmaceutical components of medical devices, and resolution of associated 483 observation

Lead quality engineering team to ensure the quality for the entire product life-cycle of electro-mechanical and disposable devices utilized for a variety of cell processing applications. Responsible for ensuring effectiveness of risk management, design control, software development, and analysis of field performance to maximize value of NPI’s.- Reduced product failure rate by over 75% for company’s most profitable product by focusing contract manufacturer on value added projects, effectively managing contract manufacturer’s execution and optimiziation of their processes- Upgraded complaint database through implementation of MS Excel Macros and Pivot Tables to facilitate real time reporting of trends and quality for critical factors including component, lot, date manufactured and customer- Qualified new RF Weld process with robust process capability to comply with stringent product quality requirements while reducing sampling costs 30% and increasing capacity, allowing the elimination of an extra shift- Implemented upgraded plasma treatment / UV curing process to eliminate severe business risk and liability associated with failure of critical joint subjected to high speed centrifugation forces associated with customer loss- Utilized statistical analysis to evaluate performance of medical devices isolating suspect devices for a Class 2 Medical device allowing accelerated root cause determination and driving corrective actions to appropriately mitigate risk- Developed statistical model to account for component, manufacturing, testing, and customer use variance to optimize product design and refocus business strategy to align more closely with customer requirements- Saved 30% on costs associated with in-process, AQL, and retain sampling through effective evaluation of risks- Led design control for Class 3 medical device that achieved IDE approval for a first of kind therapeutic application for the treatment of Critical Limb Ischemia utilizing stem cells

Valued team member of a high performing team implementing quality remediation on an accelerated schedule responsible for executing 15 TMV’s, 10 IQ’s, and 5 PQ’s on an accelerated schedule.- Overhauled ultrasonic cleaning process for Class 1 medical device product, including validation and biocompatibility testing to support 510k submission- Streamlined inspection process for optical vision system by creating macro enabled spreadsheet to automate entry of data; reducing documentation errors and reducing cycle time over 33%- Instituted change control process for verifying implementation of changes to product artwork and legal text to eliminate compliance gap that resulted in product recalls- Implemented optical vision system by successfully optimizing lighting and measurement techniques through DOE analysis to eliminate time consuming mechanical inspections, allowing 25% increase in capacity- Designed fixturing and inspection tooling for performing quality inspections of product features with sub-micron tolerances to resolve issues with accomplishing challenging test method validations

Responsible for the manufacturing of pharmaceutical/device products by supervising up to 31 associates on 5 separate product lines, while assuring adherence with quality, production, safety, and environmental goals.- Led manufacturing team in successful response to Class 1 FDA recall to allow accelerated reentry to market- Enabled successful launch of new drug/device product using revolutionary technology through creation and development of a manufacturing team of 24 associates- Created high performing team that exceeded 20 of 21 company benchmarks for engagement and morale and ranked in the top 5% globally for a Fortune 100 company- Improved OEE 300% on expedited timeline within 8 months to facilitate market expansion for new product launch by implementing lean manufacturing tools; including Kanban, Kaizen, 5S, and Gemba- Reduced batch record review cycle from over 8 days to less than 48 hours to expand product marketing phase by effectively leading multi-functional project team to implement lean tools- Integrated 4 databases to improve accuracy of data and reporting to reduce open NC’ss and CAPA’s by 80% resulting in 100% on-time product shipments- Demonstrated strong technical writing skills, through authoring of complex investigations for senior management to address critical compliance risks related to potential fatalities and subject to FDA review- Bolstered the performance of an inherited weak team by performance managing 33% of staff into termination

Selected for high potential candidate program designed to develop leadership, communication, and technical skills. Demonstrated success across different engineering functions, industries, locales, and job functions.- Selected for competitive international assignment to support two business critical projects as a result of recognized strong performance- Led test plan development strategy and authoring of test protocols for validation of a new $200M drug- Improved process capability through utilization of six sigma tools and reduce material usage 13% - Secured approval for over $2M in capital projects through financial benefits analysis and capacity analysis- Automated labor-intensive cleaning process and boosted cycle time, safety, and cost efficiency by designing pilot machine, tailored to Class 3 medical device environment in collaboration with vendors