Akshay Datar

Experience

• 

  Patange Industries Pvt. Ltd.

  May 2013 - Sept 2015

  Junior Engineer in Engineering Dept. (Process Design)

  Job Profile:• Worked as a Junior Engineer in Engineering Dept.• Assist in Component Process Design, considering the input/requirements from customer.• Preparation of bill of materials (BOM)• Preparation of part drawings, process drawings, fabrication drawing etc, by using AutoCAD – 2013.• Creation of process flow diagrams (PFD), control plans & process plans for the components. Preparing engineering change requests (ECR) and engineering change notes (ECN) for Internal as well as Customer changes.• Creating product realization documents and process validation documents for components & assembly projects for approval of Customer & Third-Party Inspection agency.• Assist in gauge & fixture design required for various components such as inspection templates, special gauges, copying masters, welding & machining fixtures, etc.• Assist in new product development activities.• Working as a team member for Continuous Improvement Process (CIP) activities. Show less

• 

  IZiel Healthcare

  Jun 2016 - Sept 2018

  Process Engineer

  Job Profile:• Lead projects and participate in daily project management meeting as a part of project management group to track project progress, assign resources, and resolve challenges to deliver projects on time.• Partner with a US based team lead to collaborate and execute projects related to process validation documentation with an on-shore/off-shore model.• Create equipment requirements specifications and IQ protocols and reports to support equipment installation and qualification process.• Create quality system procedures and work with documentation control systems to create, manage and store documents.• Train and teach on concepts related to Design for Six Sigma (DFSS) and lean manufacturing.• Conduct interviews to recruit process engineers in the company.• As a part of this profile, received extensive training on:o Requirements Managemento Six Sigma Methodologies: DMAIC, DMADV, IDOV. o Lean Manufacturingo Basic & Advanced Statistics: Regression Analysis, Design of Experiments, Measurement System Analysis, Process Capability Calculation, etc.o Cognition Cockpit: It is a Requirements Management software which is used to manage requirements, risks, verification & validation tests for a product and to create documents for these activities in compliance with 21 CFR 820. Show less

• 

  Tata Elxsi

  Oct 2018 - Apr 2022

  Job Profile • Lead project and participate in project status meeting to track project progress, allocate resources, and resolve challenges to ensure on-time delivery and to achieve quarterly target. • Lead multiple teams and participate in internal status meetings and client meetings to track delivery schedule and resolve challenges if any. • Create WSR and MSR presentations to showcase project progress to Client and Internal Management team. • Organize and lead meeting to discuss and identify CAPAs based on the Monthly Metrics Report provided by QA team and ensure implementation of the same. • Create and update project specific QMS documents such as Skill Matrix, RACI Matrix, Risk Tracker, PMHB, etc. • Participate in CC audits and ensure closure of the action items identified in the audit. • Conducting appraisal meetings within the team. • On-boarding of new resources within the team. • Participate in new project estimation activities to determine scope of work w.r.t applicable regulatory requirements. • Conduct interviews to recruit mechanical and biomedical engineers in the company. Show less Job Profile • Lead project and participate in project status meeting to track project progress, allocate resources, and resolve challenges to ensure on-time delivery and to achieve quarterly target. • Lead multiple teams and participate in internal status meetings and client meetings to track delivery schedule and resolve challenges if any. • Create WSR and MSR presentations to showcase project progress to Client and Internal Management team. • Organise and lead meeting to discuss and identify CAPAs based on the Monthly Metrics Report provided by QA team and ensure implementation of the same. • Create and update project specific QMS documents such as Skill Matrix, RACI Matrix, Risk Tracker, PMHB, etc. • Participate in CC audits and ensure closure of the action items identified in the audit. • Conducting appraisal meetings within the team. • On-boarding of new resources within the team. • Participate in new project estimation activities to determine scope of work w.r.t applicable regulatory requirements. • Conduct interviews to recruit mechanical and biomedical engineers in the company. Show less

  • Specialist (Medical Devices Regulatory Affairs)

    Jul 2021 - Apr 2022

  • Senior Engineer

    Oct 2018 - Jul 2021
• 

  Philips

  May 2022 - now

  Product Quality Engineer