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 verifications, design validations, risk management, quality plans and associated deliverables.• 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, business 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 teams.• 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 specifications and inspection plans.• 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 development.• 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 around the world. • 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• Applied statistical tools to analyze data and drive problem resolution

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

Bachelor'S Degree, Mechanical Engineering