Gowrishankar B N Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Ka, In

Pune, Maharashtra, India

Bengaluru, Karnataka, India

Working as a Process Engineer in Medical Device Manufacturing and Assembly, such as Breast Biopsy Device, Spinal Spacer implant surgical instruments, Spinal cord simulation & Deep brain Simulation instruments, RF Cannula Medical Devices, and having good communication with knowledge of ISO 13485-2016, Process validations, FMEA & DHR Responsibilities for New product development.Working on Process Verification and validation of Child Parts, Assemblies, Sub assemblies, Equipment and Fixture Validation for respective process.Roles and Responsibity: Reviewing of Customer drawings with Cross Functional Team and discuss about feasibility. Perform and participate in various trials to define suitable process and process parameters. Qualification of fixtures and Equipments. Perform Design Verification as directed by the Customer. Preparation, Execution and Review of Test Protocols for IQ, PCS, OQ and PQ. Test Method Validation (TMV) Protocols preparation and Execution (Gage R&R). Risk Management using PFMEA tool. BOM Preparation for Respective Customer standards. SPC Analysis by using ‘Minitab-19 Statistical Software’. Preparation and Review of Manufacturing documents such as Process Flow Chart/Diagram, Control Plan, Visual Check list, PFMEA, Work Instruction for Process and Measurement method. Incoming inspection, First Article Inspection, Process setup Validation, Final inspection and DHR preparation for New Projects. Preparation and Review of Master Validation Plan (MVP) and Device Master Record (DMR). Participate as well as Lead the meetings with cross functional team to communicate resource requirements, priorities and key issues / risks associated with Process and Product. Review, Analysis of customer complaints, provide Corrective and Preventive Action (CAPA) to reported problem using 8D problem solving technique.Personal Profiles:

Bengaluru, Karnataka, India

Master Of Technology - M.Tech, Industrial Automation Engineering, 9.27 Cgpa

Bachelor Of Engineering - B E, Mechanical Engineering, 8.57 Cgpa

Diploma, Mechanical Engineering, 80.31%