Pradeep Gopalakrishnan Email & Phone Number

Fridley, Minnesota, US

Fridley, Minnesota, US

• Developed design risk management documents like Risk Management Plan and Risk Analysis Chart to support New Product Development (NPD).
• Identified new & reviewed existing Product Risk scenarios, and prepared Preliminary Hazard Analysis documentation to support new product launch and product change.
• Supported Test Method and Test Method Validation preparation and execution for production support and remediation projects.
• Supported supplier setup and currently working on completing Production Part Approval Process (PPAP) process for NPD projects.
• Met day to day business needs by supporting process changes, product quality improvements, change management process, review and approval of documentation, remediation of documents, Corrective Actions and Preventive.
• Led CAPA actions as a CAPA Specialist to establish correction, implement corrective actions and preventive actions, complete Product Hold Activities and revise documentation per Quality Procedures.

Noida, Uttar Pradesh, IN

• Worked for Jabil Inc. (West Chester, PA)
• Developed and established manufacturing process and process flow to support New Product Introduction for medical device.
• Worked on Patient Specific Product Transfer between manufacturing sites and executed validation plan & verification studies to support immediate production/patient requirements.
• Validated and re-engineered existing product line with updated manufacturing process & improvements to implement streamlined product flow and improved cycle time to meet increase production demands.
• Performed and executed process and equipment validations (Installation Qualifications - IQ, Operational Qualification - OQ and Performance Qualifications - PQ).
• Performed Engineering Studies & Process tests and evaluated results to be used for future product/process development.

Tamarac, FL, US

• Worked for DePuy Synthes (West Chester, PA)
• Developed and executed Installation Qualifications at the site to support Equipment Installations and internal machine moves as per production requestSupported and executed reliability and form, fit & function studies.
• Developed and executed Operational and Performance Qualifications to release new processes and improve existing processes.
• Performed capability analysis on Minitab to support manufacturing procedure to meet process capability requirements.
• Evaluated and processed product obsolescence and discontinuation process for legacy products (product de-complexity).
• Created, reviewed and approved Document Change Orders and Manufacturing changes (Change Management).

Master'S Degree, Industrial Engineering

Bachelor Of Engineering - Be, Mechanical Engineering