Soham Chakraborty Email & Phone Number

Tempe, Arizona, US

• Provide Quality Engineering oversight and guidance to ensure product development deliverables meet internal and external regulatory requirements, including customer requirements, design specifications, design.
• Ensure maintenance of product Design History Files, Device History Records, Risk Management Files, Usability Files, and Technical Files/Design Dossiers.
• Collaborate with global operations sites to clarify design transfer process and change requests from the manufacturing facilities back to the design center.
• Lead efforts to transform design control and design change processes for San Jose design center which include software, hardware products, as well as non-medical device software systems (Medical device data systems.

San Jose, California, US

• Acted as the core team member and design control system subject matter expert for their instrument-free Rapid PCR test kits for Female STIs and Respiratory infections.
• Guided 2 core project teams throughout the design control system stage gate process.
• Identified and explained the key deliverables, reviewed DVT documentation, and provided feedback.
• Led risk management activities for their 2 major product lines as defined by the ISO 14971 standards. Additionally, assisted in creating the failure mode and effects analysis (dFMEA) documents with cross-functional.
• Implemented statistically sound sampling techniques through the design control process and in product transfer activities.
• Helped establish a risk-based sampling system for Incoming Quality and the Product Automation teams.

Franklin Lakes, New Jersey, US

• Supported the implementation of new products, processes, and changes by developing quality plans, approval of design verification plans and protocols, inspection methods, work instructions, and raw material.
• Provided quality guidance to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management (ISO 14971), and specification.
• Conducted internal and supplier audits. Additionally, provided audit support for customer and regulatory audits.
• Developed sampling plans by applying attribute, variable, and sequential sampling methods. Additionally, helped develop local procedures, test Methods, and acceptance sampling plans.
• Facilitated non-conforming product investigations, including corrective/preventive actions and product remedial actions.

Franklin Lakes, New Jersey, US

• Defined strategies/acceptance criteria for Test Method Validations, MSAs, and more than Process Validation activities (IQ, OQ, and PQ) for both new and transfer Plastic Injection Molds and Liquid Silicone Rubber molds.
• Performed Statistical data analysis related to manufacturing data and conducted more than 10 Design of Experiments for new process development activities for plastic injection molding for different BD Business Units.
• Coordinated communication between Division R&D and Plant personnel on new products, product improvements and product issues.
• Led pFMEA activities with cross-functional teams along with performing Root Cause analysis, Failure Investigations and CAPAs for several product non-conformities.

Billerica, MA, US

• Supported sustaining engineering projects by proposing drawing and specification changes, and drawings, designing test fixtures, conducting testing, and analyzing data
• Developed, recorded, and performed various failure analyses on systems and components to identify root causes
• Drafted and updated manufacturing work instructions, SOPs, and product specification documentation
• Generated technical reports and presentations on test results related to the Selective Laser Sintering process and Melt Flow Index testing
• Established root cause failure analysis techniques, processes, and test methods.
• Identified and researched failures to improve product quality and reliability related to Melt Flow Index measurement capabilities

Master'S Degree, Engineering Management (Focus: Indutrial Engineering)

Bachelor'S Degree, Mechanical Engineering