Design and develop lean/robust manufacturing processes and plans for new and existing products.Develop and maintain process standards. Document with standard work instructions, PFMEA and controls plans for compliance with ISO 13485 and customer requirements.Facilitate transfer of knowledge of best practice methods.Support cost reduction initiatives through product improvement, process optimization, sourcing, and process implementation.Manage projects by efficiently working with operations, quality, accounting, product and facilities engineering, procurement and vendors.Support and ensure compliance with safety, quality and environmental systems.

• Lead process improvement and production efficiency (scrap and up-time) initiatives utilizing Six Sigma and lean manufacturing tools.• Administer all engineering activities and recommend strategies to customer on new product development.• Interface with customers and suppliers on project matters, process capability studies, product quality issues, and automation related projects. Support quoting activities within material selection and process development.• Support supply chain and sourcing by driving cost saving initiatives by implementing alternate raw materials and improve equipment uptime by 70%. Completed Lean Six Sigma Yellow Belt and Green Belt in progress.• Conduct Failure Investigations and implement solutions (corrective and preventive actions) that solve manufacturing and product problems, follow-up on corrective and preventive actions to determine their effectiveness and suitability and prepare written reports on these activities in a timely manner.• Partner with customers to solve technical issues and determine customer requirements based on application. Assist in transition of product from prototype to production. • Independently design and conduct statistically valid, scientifically sound feasibility studies and process development projects by proficiently using Mini-tab and prepare timely written updates and report of these activities.• Evaluated and recommended equipment to implement new product development and capital improvements.• Recommended and implemented tooling design changes to enhance manufacturing output cost control.• Generate manufacturing process documentation to assure that manufacturing processes and related documentation follow established policies and procedures. • Provide training to operators and technicians as required. Oversee the implementation of new equipment.• Draft and modify component and tooling assembly drawings using Solid Works.• Draft and execute process and equipment validations (IQ/OQ/PQ).

◙Perform risk analysis to determine process criticality and appropriateness of controls in alignment to Company's Risk Management Policy.◙Perform Test method validations.◙Perform Design Transfer to demonstrate all design outputs are successfully implemented in production in a compliant state.◙Provide manufacturing engineering to create, document and implement required procedures and documents while ensuring full compliance with GMP’s. Conduct testing, prototype development, tooling review and recommendations, product and tooling quotes, development of manufacturing processes and testing standards. Complete internal qualification process on all tools for manufacturing.◙Implements process validation (IQ, OQ, PQ, TMV) activities to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies’ requirements and Quality Modules.◙Provide recommendations to remediate any deficiencies.Working on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results

MS in Plastics Engineering

◙Performed Aerospace Wire & Cable quality improvement through defect analysis and implementing corrective actions within Manufacturing department for extrusion of cables◙Performed DOEs to cut scrap, improve manufacturing process by monitoring performance and initiating actions to optimize equipment