Nirav V Email & Phone Number

Minneapolis, MN, US

Minneapolis, MN, US

• Designed and developed manufacturing processes, inspection instructions and quality procedures for medical devices, ensuring compliance with regulatory requirement and standard (FDA 21 CFR 820, ISO 13485)
• Generated and executed Installation, Operational and Performance/Process Qualification (IQ, OQ, PQ) protocols and final reports for process validation and remediation projects.
• Performed Equipment Installation Qualification (IQ) for the new and modified equipment.
• Collaborated with cross-functional teams to resolve process-related issues and updated the manufacturing processes.
• Participated in internal and external audits to ensure compliance with FDA regulations, ISO standards, and GMP requirements.
• Developed and performed Test Method Validation (TMVs) to validate the test methods.

Pomona, CA, US

• Performed new and identical Equipment qualification including IQ, Test Method Validation (TMV) requirement, software validation.
• Drafted Equipment specification, and calibration and preventive maintenance requirement and performed the calibration and inhouse or supplier preventive maintenance keeping the equipment master list up to date with all.
• Conducted safety, Cgmp and GDP guideline training for the assembly line workers to ensure the Cgmp compliance.
• Reviewed production Batch records, Lot history records to ensure the compliance with the company policies and revise Standard operating Procedures (SOPs).
• Supported the creation and maintenance of company quality documentation such as quality manuals, quality procedures, etc.
• Collaborated with Supplier and Engineering team to support material changes resulting from Change action, plan for new material and minimize obsolescence of old material.

Cleveland, Ohio, US

• Developed specific printing profiles and process for different types of plastic material for Additive Manufacturing (AM). Monitored and recorded machine procedures to ensure optimum balance between speed and quality.
• Prepared 3D models using SolidWorks and CAD software for 3D-printing. Worked on new material projects (internal and external) from planning to execution.
• Reviewed approval drawings of parts and created report showing areas which require design change recommendation. Performed quality checks. Suggested and tested improvements in the printing processes.
• Coordinated Tech Service and Support activities for new and existing providers of equipment and machinery.
• Coordinated preventive maintenance, calibration, verification, inspections as per schedule on the 3D printers.

Cleveland, Ohio, US

• Provided individual and/or group assistance to students in subject areas such as machine design, manufacturing processes, measurement, and machine analysis. Graded class assignments & exams for selected courses.
• Executed of all safety assessment for the new lab equipment or process implementation within measurement lab.
• Set up and led weekly lab session. Conducted technical presentations. Taught SolidWorks 2D drawing, 3D modelling, FEA and sheet metal.

Master Of Science - Ms, Mechanical Engineering

Bachelor Of Engineering - Be, Mechanical Engineering