
Timeline
About me
New Product Development Engineering - Regulated Products
Education
Educational Institution
-Aas engineering scienceThe johns hopkins university
2000 - 2005Bs mechanical engineering3.95 GPA
Experience
W.r. grace
Jan 1990 - Apr 2005•Dual role of plant supervisor and process engineer responsible for all operational aspects of the Organometallic Catalyst Plant.Reported to the Polyolefin Catalysts Superintendent with responsibility for safety, budget, inventory, production scheduling, quality, and process engineering. Supervised plant operators and maintenance mechanics. Maintained compliance with OSHA Process Safety Management (PSM) requirements. Managed process development, semi-commercial, and pilot plant activity. Reported to the Polyolefin Catalysts Director of R&D with responsibility for process engineering and safety. Supervised R&D technicians.
Process Supervisor
Jan 1998 - Apr 2005Senior Engineer
Jan 1990 - Dec 1997
W. l. gore & associates
May 2005 - Feb 2007Process engineerManaged process and product improvement projects for medical device manufacturing processes. Performed validation of changes in accordance with FDA and ISO guidelines. Designed, executed, and analyzed experiments using statistical analysis tools. Evaluated proposed changes based on analysis of regulatory, quality, ergonomic, safety, and environmental requirements.
Rogers corporation
Feb 2007 - Oct 2008Principal project engineerManaged capital and process improvement projects for the commercial manufacturing area. Provided oversight in the development of systems to measure Overall Equipment Effectiveness (OEE). Mentored junior process engineers.
St. jude medical
Apr 2009 - Nov 2013Responsible for the hybrid manufacturing process with primary goals of WIP and Lead Time reduction through the implementation of process control strategies based on the principles of Lean, Six Sigma, and the Theory of Constraints. Defined and implemented performance metrics to prioritize and manage the day to day manufacturing workload. Created and maintained a Value Stream Map of the varied manufacturing processes. Utilized the map to identify and prioritize opportunities for improvement, maintenance, and capital expenditures. Provided leadership and guidance to Production Supervisors and Process Coordinators. Directed and prioritized the work of Process Engineers towards reduction of waste and rework. Primary manufacturing representative on new product introduction teams. Show less Responsible for continuous operation and maintenance of cleanroom facilities and utilities for manufacture of hybrid electronic devices. Managed the reconfiguration of two manufacturing lines within the cleanroom, aligning the production equipment with the process flow. The complete reconfiguration of the manufacturing floor layour was accomplished over a period of six months with no measurable impact on manufacturing rates during that time.Implemented ISO 14644 at the site by validation of the cleanroom to the standard and revision of the cleanroom specification incorporating the ISO standard.Installed new vacuum pumps saving more than 50% in energy costs over the existing equipment. Show less
Manufacturing Engineer
Sept 2012 - Nov 2013Site Facilities Manager
Sept 2010 - Aug 2012SBU Group Leader
Apr 2009 - Sept 2010
Njoy electronic cigarettes
Jan 2014 - Aug 2016• Characterize devices and develop improvement strategies. Validate improvements and drive implementation at Chinese contract manufacturers. • Implement GMP compliant systems and processes for the manufacture of electronic cigarettes. Implement those systems and processes at Chinese contract manufacturers. • Develop and implement SPC systems and reporting. Manage the implementation of SPC at multiple Chinese contract manufacturers. • Create product specifications and statistically sound acceptance criteria for high volume manufacturing.• Drive development of performance requirements and test methods. Provide leadership in the validation of test equipment and methods.• Lead product development and improvement teams.• Participate in compliance audits of API, device, and liquid formulation suppliers in the EU, China, and the US.• Investigate product defects and complaints, implementing CAPA’s. Provide technical support to customer service group. Show less
Director of Product Development
Aug 2015 - Aug 2016Quality Engineering Manager
Jan 2014 - Jul 2015
Dmaic engineering, llc
Dec 2015 - Dec 2023PrincipalEngineering consultant.
Jupiter research, llc
Aug 2016 - Jan 2019Vp engineeringDirect all engineering and quality functions. Provide technical support to sales and marketing. Manage technical development of new products and product improvements at contract manufacturing partners. Provide primary engineering for development of new hardware and systems. Perform feasibility analysis of new product ideas. Provide analysis of existing product portfolio in comparison to the current and evolving market and the state of the art.
Njoy
Jul 2019 - Dec 2023Sr. Director, New Product Dev., Mechanical
Jul 2022 - Dec 2023Director, Technology and Engineering Standards
Jul 2019 - Aug 2022
Licenses & Certifications
Six sigma green belt
Sigma breakthrough technologies, inc.Feb 2000
Volunteer Experience
Youth Sports Coach
Issued by NSSC and Prime Time AthleticsAssociated with David Schuler
Languages
- enEnglish
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