Nirav Desai Pe, Pmp, Csm, Safe 6 Agilist Email & Phone Number

United States

New Brunswick, Nj, Us

⬧ Reduced development costs by 25 percent by creating a plan to merge related products into one, more streamlined product. ⬧ Reduced production cycle time by 76% while keeping safety standards through effective risk mitigation strategies. ⬧ Managed a team of 30 engineers that delivered projects 3 days ahead of schedule and within a lean $3MM budget while keeping the highest quality standards in the industry. ⬧ Worked with team of 12 project managers and coordinators effectively ensure the prompt delivery of projects on time within budget and high-quality standards. ⬧ Perform project goal and scope definition, capital cost, project planning, and scheduling. ⬧ Lead all aspects of projects, including planning, resource allocation, project documentation, client engagement, and change management. ⬧ Address and resolve project risks, roadblocks, and obstacles while securing resources to efficiently complete deliverables. ⬧ Lead projects for new product development. Set overall project goals, plan schedules, define direction & contribute to other functional areas as needed. ⬧ Established strategic direction for CAPA and Complaint activities aligned with business and quality initiatives and in compliance with all regulatory requirements. ⬧ Interfaced with management, peers, and subordinates to assess and improve adequacy of processes, which includes but not limited to remediation efforts of CAPA, Complaint, and Nonconformity (NC) deficiencies found in internal audits and/or inspections.⬧ Build a machine-learning-based system for new product development process with identical product database to Identify Increased customer retention by 30% for the product group with Al, Machine learning and generative Al algorithms, LLM, NLU and NLP. ⬧ Increased vendor product quality by 25% implementing KNN, K-means and Ensemble classification models to identify quality suppliers for medical devices components with Al, Machine learning, Gen AI, LLM, NLP.

Forchheim, De

⬧ Succeeded in managing a quarterly budget of $900K across 23 departments, including engineering, manufacturing, and quality assurance. ⬧ Reduced project cycle time by 60% while maintaining safety standards through effective risk mitigation strategies. ⬧ Partnered with teams of 15 contractors that completed projects within deadlines and 34% under budget on average. ⬧ Supervised 15 projects with budgets above $888K, including 9 other projects worth S1M each. ⬧ Built relationships with 150 customers that contributed materially to over S800K in repeat business. ⬧ Conducted root cause analysis on project issues and developed actionable recommendations to mitigate future risks. ⬧ Utilized analytical and technical expertise to provide insights and proposals to support business improvements. Evaluated analytical model findings in the global monitoring report, the company's flagship product. ⬧ Conducted business analysis to understand business needs and requirements to translate into conceptual designs. Actively engaged in the quantitative analysis of sophisticated modeling to address business issues. ⬧ Spread headed development and formulation of CAPA related projects that’s resulted in determining the correct root cause of compliance related issues ⬧ Data mining or extracting usable data from valuable data sources. ⬧ Created and executed over 500 new or updated procedures to ensure flawless implementation and adoption of new processes.⬧ Review and approve contract details and coordinate with vendors outside contractors, scope, schedule, and budget. ⬧ Analyzes trends to monitor effectiveness of CAPA and Complaints processes and drive remediation for improvement. ⬧ Preparing reports for the management stating trends, patterns, and predictions using relevant data using Tableau and SQL.⬧ Analyzing local, national, and global trends that impact both the organization and the industry. Processing, cleansing, and validating the integrity of data.

Lyndhurst, New Jersey, Us

⬧ Developing and maintaining data systems – reorganizing data in a readable format. Performing analysis to assess quality and meaning of data. ⬧ Preparing reports for the management stating trends, patterns, and predictions using relevant data. ⬧ Filter Data by reviewing reports and performance indicators to identify and correct code problems.⬧ Built relationships with 150 customers that contributed materially to over S800K in repeat business. ⬧ Collaborated with across departments on a variety of projects, increasing inter departmental communication by 70% YoY. ⬧ Delivered redesign processes and products to upper management supporting quality improvements and projected cost savings. ⬧ Collaborated with cross-functional departments to ensure timely project execution. ⬧ Demonstrated expertise in applied research, new concept development, simulation and validation supporting engineering and production areas. ⬧ Developed streamlined design protocols for existing/new products and prototype testing resulting in improved manufacturing efficiency by 50%. ⬧ Created and executed over 500 new or updated procedures to ensure flawless implementation and adoption of new processes. ⬧ Implemented data analysis methodologies to measure project performance, identify areas for improvement, and suggest solutions to project managers.

Master Of Science (Ms), Data Science And Analytics

Master Of Science (Ms), Mechanical Engineering

Bachelor Of Science (Bs), Mechanical Engineering