NAVNEET BANSAL
Engineering Project Manager
Basel
Summary
Talented professional considered knowledgeable leader and dedicated problem solver. Brings 18 years of valuable expertise to forward company objectives. Attentive to detail with experience in coordinating projects, programs and improvements.Experience in Project Lifecycle Management and New Product Introduction from concept to market launch following Medical Device standards and regulations ISO 13485, ISO 14971, Regulation EU MDR 2017/745, 21CFR 820. Proven track record of managing complex development projects in a highly regulated environment. Applying creative and analytical approaches to operations for continuous process improvement. Skilled at identifying or anticipating problems and providing solutions.
Overview
19
19
years of professional experience
4
4
years of post-secondary education
4
4
Certificates
4
4
Languages
Work History
R&D Project/Program Manager
DePuy Synthes – Switzerland
Basel
07.2018 - Current
- Responsible for Program/Project Management, and coordination of complex projects spread across different geographies
- Reporting Project Metrics, controlling scope, time, and budget regularly
- Determine and communicate Project Plans, Resource requirements, Budget Inputs, and Schedules to business unit and project teams to ensure accurate expectations
- Coordinate with cross-functional team local/global and developed metrics to meet project goals
- Collaboration with a Cross-functional team of Engineers and Subject matter experts, implement project plans, drive team meetings, and facilitate goal setting and tracking to ensure adherence to plan and strategy
- Promptly identify team conflicts, issues, or delays and work with affected personnel to resolve issues
- Conduct Retrospective Review (Team Retro) and plan for continual improvement, empowering the team to self-organize
- Took Initiative and Collaborated with business users, technical teams, database administrators, and testing teams to develop and enhance the database resulting in maximized team resources and management
- Collaborated closely with Supply Chain, Operations, and Regulatory teams, addressing design verification and validation concerns, clarifying technical documentation, and supply details regarding standard operating procedures, fostering a strong working relationship, and ensuring a thorough understanding of the EU MDR 2017/745 Submissions
- Management of the CAPA (Corrective Action Preventive Action) system in collaboration with internal and external process owners to ensure the implementation of appropriate corrective and preventive actions
- Supply Chain R&D – Product transfer to a new supplier for manufacturing, validating processes, equipment, and methods
- Met with project stakeholders on regular basis to assess progress and make adjustments.
- Coached team members on productivity strategies to accomplish challenging goals.
- Interacted with customers and clients to identify business needs and requirements.
- Established milestones and objectives based on input from functional areas and stakeholders.
- Identified program obstacles and communicated possible impacts to team.
- Leveraged project management processes and tools to define and execute projects.
- Provided program management expertise in lean Six Sigma strategies and agile methods, practices and execution.
- Engaged and worked alongside cross-functional stakeholders to manage strategic initiatives.
- Collaborated with business leadership to set priorities based on business needs, resource capacity and risk exposure.
- Managed multiple strategic projects with numerous sub-projects or workstreams.
Project Manager
Dutch Ophthalmic Research Center
Amsterdam
07.2017 - 07.2018
- Tech-File GAP Assessment and Remediation, built successful project plans covering objectives, resources, and staffing to meet schedules
- Adhered to budget requirements with excellent planning and consistent expense monitoring
- Set up communication channels with local/global teams to track project challenges and progress
- Maintained open communication by presenting regular updates on project status and technical problems to customers
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules, and conflicts
- Authored risk management documents consisting of the risk management plan, risk assessments, and risk management report in alignment with the requirements of ISO14971, and ISO13485
- Experience in Post Market Surveillance Support, Analysis of Complaint Data of predicate devices, Manufacturing quality database, MAUDE data to look for any new failure modes for competitor predicates
- Developed Investigation actions, perform Root Cause Analysis, identify Implementation actions to address Root Cause, and monitor the effectiveness of implemented actions.
- Met project deadlines without sacrificing build quality or workplace safety.
- Achieved project deadlines by coordinating with contractors to manage performance.
- Developed and implemented strategic project plans to meet business objectives.
- Provided detailed project status updates to stakeholders and executive management.
- Drafted project reports to identify successful outcomes, insights and future recommendations.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Provided detailed technical and operational direction in project challenges, consistently meeting deliverables according to deadlines.
- Tracked project and team member performance closely to quickly intervene in mistakes or delays.
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
- Developed and implemented project plans and budgets to ensure successful execution.
Technical Manager
DePuy Synthes, Through HCL Technologies Limited
04.2015 - 06.2017
- Tech-File Remediation and Tech-File GAP analysis to meetRegulatory requirements
- Developed suggestions for technical process improvements to optimize resources.
- Worked closely with customers to evaluate various types of risks such as impact, reputation and regulatory.
- Gathered requirements and maintained communication between project teams, internal clients and external stakeholders.
- Prepared status charts for daily management meetings in Excel and PowerPoint.
- Communicated project status, delivering audience messages and change management with clients.
- Met with clients to gather and understand requirements and coordinated with system administrators and directors to plan and schedule project activities.
- Expertise in Risk Management, especially in project risks, dFMEA, pFMEA, and patient risk analyses with the requirements of ISO14971, and ISO13485
- Coordinated with external suppliers to evaluate the manufacturing process and monitor any production risk
- Collaborated with customers to evaluate distinct types of risks and impacts.
Product Development Lead
Medtronic Inc, Tata Consultancy Services
10.2012 - 04.2015
- Experience in New Product Development End to End process from Concept Development to Market Lunch
- Hand-on experience in Concept generation, Feasibility Study, Design & Development Plan, and Risk Analysis
- Prototyping, Testing, Verification, and validation Activities
- Conducted phase review meetings with customers
- Interacted and collaborated with cross-functional teams i.e., Design, Manufacturing, Quality, and Regulatory.
Technical Lead
Stryker Global Technology Center
09.2007 - 07.2012
- Specialty/Customize Orthopedic Instruments, Developed New/Customized, Knee/Hip Instruments for better leverage and cost-effectiveness, accountable for End-to-End process from VOC to Market launch, Concepts generation, verification, and validation activities, and design review meetings with cross-functional teams
- Customized existing Knee instruments and enhanced functionality by replacing single feature with multiple features instruments and reducing cost
- Developed metal prototypes in India and executed Cadaver Lab in Australia – Achievement
- Design & Development of Knee Implant & Instruments, Knee Instruments following design control process in compliance with ISO 13485, CFR 820
- Experience in 3D parametric modeling & drafting using Creo, and application of GD&T
R&D Engineer
Sona Koyo Steering Systems Limited
Gurgaon
04.2005 - 09.2007
- Developed an Off-Highway Vehicle Steering system, responsible for CAD Modeling and Engineering drawings of aluminum casting for steering housing
- Idea generation to assemble physical samples for field testing without changing vehicle geometry -Achievement
- Interacted with customers to obtain critical design information necessary to complete projects within the intended times
- Managed multiple tasks and met time-sensitive deadlines
- Experience in 3D parametric modeling & drafting using Creo, and application of GD&T
CAD Engineer
CADD Centre
04.2004 - 04.2005
- Designed high-quality, robust, and cost-effective CAD product models by preparing routine layouts, detailed drawings, assembly sketches, and diagrams
- Responsible for CAD models and engineering drawings of aluminum casting & forging components, Tool/Die sheet metal components, Checking Gauge
- Experience in 3D parametric modeling & drafting using Creo.
Education
B. Tech - Mechanical Engineering
Institute of Engineering & Technology, Dr. Bhim Rao Ambedkar University
India 06.1999 - 07.2003
Skills
Teamwork and collaborationundefined
Accomplishments
- Planned, designed, and developed tools - achieved a 28% uplift in efficiency
- Effectively managed a global team of over 42+ Engineers and Subject Matter experts
- Innovation Award for Customize Instruments project - improved quality by 22%, cut lead times by 35%, cut costs by 28%
- Top CONTRIBUTOR AWARD for EU MDR Biocom/TOX support
Certification
Agile Certified Practitioner (PMI-ACP)
Timeline
Agile Certified Practitioner (PMI-ACP)
11-2022
Management Essential” from Harvard Business School
06-2022
Scrum Master
02-2021
R&D Project/Program Manager
DePuy Synthes – Switzerland
07.2018 - Current
Project Manager
Dutch Ophthalmic Research Center
07.2017 - 07.2018
Technical Manager
DePuy Synthes, Through HCL Technologies Limited
04.2015 - 06.2017
Product Development Lead
Medtronic Inc, Tata Consultancy Services
10.2012 - 04.2015
Technical Lead
Stryker Global Technology Center
09.2007 - 07.2012
R&D Engineer
Sona Koyo Steering Systems Limited
04.2005 - 09.2007
CAD Engineer
CADD Centre
04.2004 - 04.2005
Master in computer Aided Tool Engineering
01-2004
B. Tech - Mechanical Engineering
Institute of Engineering & Technology, Dr. Bhim Rao Ambedkar University
06.1999 - 07.2003
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