Jayen Desai Email & Phone Number

New York, Ny, Us

New York, New York, United States

Oversaw new product transitions from development to production, ensuring quality standards, cost control, and timely delivery. Led a cost-saving initiative that reduced labor and increase line capacity through automated solutions. Managed SATs and machine qualifications, optimizing performance via statistical data analysis. Conducted Gemba walks to enhance production quality, reduce lead times, and minimize costs. Reviewed feasibility studies and engineering specifications, developed SOPs, and supported BOM setup, engineering changes, and process improvements. Provided stakeholders with critical insights on pricing, resource needs, and production rates to facilitate efficient decision-making.

Jaffrey, New Hampshire, United States

Managed quality and risk management projects, focusing on continuous improvement across two manufacturing areas. Supported TFF filter manufacturing by addressing non-conformances, deviations, and customer complaints, and led CAPA initiatives that achieved $20,000 in annual savings through tool refurbishment. Conducted process validations and equipment qualifications using statistical analysis, and authored essential documentation including SOPs and validation protocols. Supported audits, trained staff on GDP, GMP, and ISO 9001 standards, and enhanced product quality through data analysis. Implemented initiatives that reduced customer complaints by 3%, cut batch release time by 50%, eliminated bioburden excursions, and improved product specs by 25%.

Arcadia, Wisconsin, United States

Developed test fixtures and methods for products and packaging, establishing SOPs and applying Lean tools to improve quality, safety, and ergonomics in QC labs. Created test protocols for supplier qualification, conducted failure investigations, and used statistical tools to resolve issues. Monitored KPIs through trend charts and supplier scorecards, reviewed SCARs, and implemented IQC, IPQC, and AQL sampling plans. Conducted equipment validation and Gage R&R for QC inspections.

Skaneateles Falls, New York, United States

Ensured compliance with EU MDR for class I and II medical devices using design control and supported Risk Management (FMEAs, Risk Assessment Summaries) per ISO 14971. Led project plans, test protocol creation, and verification testing with cross-functional teams. Completed design verification/validation reports, provided weekly status updates to senior management, and managed the migration of legacy documents to new, compliant templates.

Skaneateles Falls, New York, United States

Supported NPI, process development, and validation (IQ, OQ, PQ, TMV) per FDA 21CFR 820, and deployed manufacturing processes, automated test equipment, fixtures, and tooling. Utilized statistical tools (SPC, DOE, Process Capability, Hypothesis Testing) and FMEAs to optimize critical processes, driving Cp/Cpk > 1.33. Authored test protocols, performed troubleshooting, and led a project that saved $10k by reusing legacy equipment. Reduced measurement variation by 10% through Gage R&R, RCA tools, and operator training. Qualified automated test equipment using MSA, developed schedules, V&V strategies, and Lean methods, and created preventive maintenance schedules for tools and fixtures.

Rochester, New York, United States

Assisted the instructor with organizing materials, facilitating group discussions, and providing technical support during lectures and laboratory sessions. Conducted office hours to address student concerns, ensured safety protocols in labs, and provided troubleshooting assistance. Graded assignments, maintained student records, and handled administrative tasks like attendance and communication. Collaborated with other teaching assistants to ensure consistency and participated in departmental meetings and training.

Danvers, Massachusetts, United States

Supported Kaizen events and applied lean methodologies to improve the MRB process. Enhanced incoming inspections through Gage R&R, tracked and trended data in manufacturing, and used data visualization for KPI tracking. Prioritized defects using Pareto analysis, leading to a 3% yield improvement and a 50% reduction in supplier defects. Developed Process Validation protocols, NCMRs, and SCARs to drive continuous improvement.

Master'S Degree, Manufacturing Engineering

Bachelor Of Engineering - Be, Mechanical Engineering