Nitesh Jain

Experience

• 

  Bosch

  Jul 2007 - Jul 2008

  Engineer

  Graduate Apprenticeship in Lean Manufacturing with focus on creating the Value Stream Maps , Consumption based manufacturing , and Controlled Inventory within plant Logistics.• Developing new process concepts for production optimization, yield improvement and developing guidelines for the sequencing of manufacturing activities on the shop floor.• Perform Value Stream Mapping (VSM) and Value Stream Design (VSD) for the department.• Responsible for preparing Monthly Metrics for the Value Stream.• Implementation of Flow Oriented Layout. • Minimizing performance bottlenecks by implementation of Consumption based production (PULL SYSTEM).• Increasing production capacity of the existing Fittings Sub Assembly for Ramp up using MTM method of improving workstations.• Undertaking lay out modification for optimized man-material flow.• Implementation of Shop floor Management Control Cycle.• Implementation of SYSTEM CIP and POINT CIP projects.• Enhancing Employee involvement and empowerment through KAIZEN, Suggestions, Waste Elimination Projects, etc. Show less

• 

  Bosch USA

  Jul 2008 - Jul 2012

  Testing for SAP PP module Process Improvements in SAP PP with PEXProviding First hand support and troubleshooting to end usersArranging SAP PP training Process ImprovementsRPP projectsMachine Commissioning and Try outsImplementation of Lean ManufacturingIndustrial Engineering and layoutingNew Product releaseIndirect Purchasing Transfer ProjectsData Security partner

  • SAP PP Key User

    Aug 2008 - Jul 2012

  • Senior Manufacturing Engineer

    Jul 2008 - Jul 2012
• 

  Stryker

  Jul 2012 - now

  - Managing Design Assurance for New product development , Product Sustenance and Patient Specific Solution, Software Design Assurance in addition to Sterility , Biocompatibility and Chemistry teams-Driving collaboration across globe to formulate and drive global departmental strategies- Developing talent and retention by mentoring and coaching to build highly engaged teams to enhance organizational capabilities- Calibrating talent to building high performing teams-Identifying gaps in people skillset to help them to effectively deliver in their roles and responsibilities Show less - Managing Design Assurance for New product development , Product Sustenance and Patient Specific Solution, Software Design Assurance in addition to Sterility , Biocompatibility and Chemistry teams-Driving collaboration across globe to formulate and drive global departmental strategies- Developing talent and retention by mentoring and coaching to build highly engaged teams to enhance organizational capabilities- Calibrating talent to building high performing teams-Identifying gaps in people skillset to help them to effectively deliver in their roles and responsibilities Show less • Leading Risk Management per ISO 14971: Risk Management for Medical Devices• Risk Management: Risk Analysis and Risk Evaluation for newly Designed medical devices and related instruments and accessories along with assessing changes in existing product design.• Driving process improvements in areas related to New product Designs.• Hazard - Harm Analysis for new designs and patient specific solutions• Assessing designs for new customization as per customer (user) needs and their further translation to Design input and output features.• Confirming design as per Design Control Documents and as per organisational Quality Management System.• Confirming all necessary requirements being fulfilled before design transfers to production as per organisational defined guidelines. Show less Leading as Individual contributor in capacity of Advanced Quality Engineer with key emphasis on quality and delivery.• Responsible for timely reporting to FDA for events falling under 'Reportability' criterion as FDA guidelines in Complaint Handling Vertical.• Creating Change Orders and Change details for the changes related to process. • Creating and modifying QIPs for Instruments viz. Hand piece, Power Units, Accessories.• Leading Engineering Change Order Process.• Creating the Validation reports, Performance Qualification Protocols for Software Validation• Assessing Reports and subsequent submission of eMDRs as per FDA regulations.• Project Management as per PMBOK® methodology. Show less

  • Product Development Manager

    Apr 2024 - now

  • Manager, Design Assurance

    Mar 2023 - Mar 2024

  • Associate Manager, Design Assurance

    Mar 2020 - Feb 2023

  • Team Lead

    Aug 2019 - Feb 2020

  • Staff Engineer , Design Assurance

    Mar 2017 - Aug 2019

  • Senior Quality Engineer

    Jul 2012 - Feb 2017