Akram Chaudhry

** ******* *****

Attleboro, MA **703

ac01a3@r.postjobfree.com

774-***-****

US Citizen

SUMMARY:

Senior manufacturing/process engineer with years of experience in developing, improving and transferring processes to contract manufacturing (CM) sites. Experienced within quality systems, and validation (IQ, OQ, PQ), FEMA, DMAIC, Gage R&R, NCR and statistical process control (SPC). Experienced in providing detailed engineering analysis and documentation, SOPS, work instructions for operators. Improving yields, quality and reducing operational costs. Designing test fixtures and tooling for existing and new products. Training manufacturing staff, troubleshooting equipment and processes, managing work streams.

PROFESSIONAL EXPERIENCE:

Medtronic/Covidien Inc. Mansfield, Ma 2016 – Present

Senior Manufacturing/Process Engineer

Responsible for transferring and supporting of Medtronic products and processes to Contract Manufacturing (CM) sites.

Managing and participating as a team with Quality, R&D, Sustaining Engineering, procurement, and Contract manufacturing Organization to ensure successful transfer and ongoing production of Finished Medical Devices at Contract Manufacturers (CM’s).

Managing technical aspects of product and process transition to contract manufacturing partners.

Ensuring manufacturing processes adequately demonstrate specified process control capabilities.

Providing technical support and guidance to Contract Manufacturer for engineering issues.

Conducting, coordinating and aiding in formal process validations including protocol development and execution.

Managing all aspects of ECO process into Contract Manufacturing organization.

Ensuring new processes have adequately demonstrated specified process and test control capabilities, through being the champion of PFMEA, DFM, DFT, DFSS, CAPA and NCR.

Providing guidance to Contract Manufacturer in designs and evaluating new and existing fixtures and equipment, test methods, specifications, layouts and standards supporting a lean manufacturing environment.

Ensuring adherence to product specifications, industry standards and FDA Quality Systems Regulations and ISO Quality Systems.

Supporting process verification and validation activities.

Selecting and Qualifying new materials and suppliers.

BRIDGEMEDICA Inc. - Medical Device Contract Manufacturing

Senior Manufacturing Engineer (Consultant/Contractor) 2015 – 2016 Mansfield, MA

Provided daily production support to set up, trouble shoot, and monitor manufacturing medical device related assembly processes and equipment.

Identified and implemented programs that reduced operational costs, improved quality, productivity and increase yield.

Created, developed, and maintained written instructions for manufacturing processes.

Developed and implemented process controls for manufacturing to ensure repeatability, reliability, and quality of products and processes.

Performed Validations (IQs/OQs/PQs) following internal protocols when new or used equipment is identified for use in production.

Led process evaluations/process optimization utilizing tools such as SPC, DOE, PFEMA and, MSA.

Responsible for establishing the Manufacturing Quality Plan (MQP) for a product line including process flow, production floor layout, equipment and line balancing.

Participated in the introduction of new products into manufacturing, collaborating with R&D and suppliers to improve product robustness and manufacturability both pre-and post- release.

Conducted root cause failure analysis and corrective action.

Led Lean Six Sigma projects of significant scope and complexity.

Supported business development, ISO 13485 compliance activities, risk management/FEMA activities, audits and technical training.

Smith and Nephew Corporation

SR. Process/Manufacturing engineer 2012 – 2015 Mansfield, MA

Provided leadership to manufacturing engineering activities for process/product development, scaling of technical operations and provided technical support for production.

Identified and implemented programs that reduced operational costs, improved quality, productivity and increased yield.

Optimized manufacturing processes and equipment.

Created, developed, and maintained written instructions for manufacturing processes.

Developed and implemented process controls for manufacturing to ensure repeatability, reliability, and quality of products and processes.

Provided training to production personnel on processes and equipment.

Worked with Research and Development in the transition of products into production.

Actively participated in the development of new products and processes to promote business growth and productivity targets, including scale-up, equipment and process qualification and validation.

Reviewed product field returns to determine root cause of potential manufacturing defects then developed and implemented effective corrective actions

Utilizing Lean/Six Sigma manufacturing methods to improve processes and reduced waste.

Drove root cause identification and resolution of process and product upsets.

Monitored and improved processes using statistics and SPC.

Dow Chemical 2006 –2012 Marlboro, MA

SR. Process Engineer

Provided technical leadership implementing major capital projects.

Provided hands-on problem solving support to manufacturing/testing of specialty chemicals.

Identified and led activities for improvements related to safety, cost, quality, yields, capacity, and production goals.

Optimized processes using Lean manufacturing and six sigma methodology, developed and implemented improvements to processes and production operations, resulting in 36% improvement in productivity.

Analyzed operating data from manufacturing processes using statistical tools, both proactively (statistical quality/process control) and reactively (troubleshooting).

Assisted both production and maintenance personnel in troubleshooting and correcting problems related to yields, quality and environmental compliance.

As necessary, assisted area leadership and developed leadership skills through interaction within manufacturing team.

Allegro Microsystem Inc. 1994 –2006 Worcester, MA

Senior Process Engineer

Supported all manufacturing areas used in the fabrication of IC’s and sensor products during 12 hour shift.

Developed and improved manufacturing methods and procedures and equipment directed at reducing costs while maintaining quality standards.

Developed quality specifications and requirements for all products.

Supervised staff of 8 process engineering personnel.

Appropriately dispositioned discrepant material using NCR system

EDUCATION

Bachelor of Science - Chemical Engineering, University of Massachusetts. MA

Lean manufacturing/six sigma- Green belt - Quantum Leap Engineering, MA

Certificate/Diploma in Microelectronics and Computer technology - Northeastern University, Boston. MA

Courses in Statistical Process Control, Process Mapping- Northeastern University, Boston. MA

8-Step Problem solving and Kaizen event classes

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