Sushmitha Udutha

• Established and monitored key performance indicators (KPIs) to achieve quality objectives.
• Conducted root cause analysis on detected faults and formulated corrective actions.
• Reviewed and classified product complaints regarding identity, quality, reliability, safety, and effectiveness of medical devices.
• Evaluated reporting criteria for Government Agencies to assess potential risks associated with devices.
• Facilitated training sessions for new employees on company policies and procedures.
• Created training materials to guide new hires through company operations.
• Organized client meetings to communicate project updates effectively.
• Delegated tasks based on department needs to enhance production efficiency.

Stretch project assignment:

• Prepared comprehensive documentation in accordance with internal SOPs and Design Control standards.
• Verified design requirements according to ISO standards and core specifications.
• Utilized Agile, Asana, Windchill, Creo, Trackwise for project management.
• Designed and executed test plans for product validation and reliability assessment.
• Promptly identified customer needs and addressed inquiries to enhance satisfaction.
• Managed time effectively to complete tasks within established deadlines.
• Collaborated with team members to achieve project objectives and ensure timely delivery.
• Worked with diverse coworkers to resolve issues and attain organizational goals.

• Prepared and set up CAD drawings, redlines, and Agile part setups per ER and ASME standards.
• Checked Agile data fields for part releases to ensure compliance with specifications.
• Documented engineering activities in accordance with established procedures.
• Conducted feasibility research on design and performance of components or systems.
• Completed regulatory documentation addressing safety issues effectively.
• Participated in team meetings to provide updates on project progress.
• Utilized Agile, Windchill, and Creo software for engineering tasks.

• Executed Titan TO Inserter PDE role for SP4.33 DCP process to enhance design accuracy.
• Led Revision Surgeries and Design X projects, ensuring adherence to SP4.33 standards.
• Managed NPI projects for Reducer and Extender, overseeing timelines for Connectors and Z-rods.
• Directed Phase 2 Revision set surgeries, focusing on implants and instruments within DCP framework.
• Monitored project deliverables according to SP4.33, ensuring timely completion of cross-functional tasks.
• Designed new processes to improve product efficiency and effectiveness.
• Delivered projects within budget and on schedule.
• Tracked project progress against timeline, ensuring compliance with all applicable regulations.

• Executed mass release of Titan spinal acquisition products in Agile framework, ensuring compliance with EUMDR regulations.
• Developed project plans and estimations to streamline product launch processes.
• Authored documentation for standardization of release change requirements per MSB standards.
• Facilitated effective communication among teams to ensure alignment with project objectives.

• Validated design according to DFMECA standards using tolerance stacks and finite element analysis.
• Ensured compliance with ISO and core design requirements through rigorous validation processes.
• Developed mechanical designs and details for plastic and sheet metal components of robotic surgery devices.
• Collaborated with project manager and engineering team to discuss design specifications and procedures.
• Utilized various software and tools to streamline processes and optimize performance.

• Verified design requirements in compliance with ISO standards and core specifications.
• Utilized Agile methodologies to enhance project efficiency and adaptability.
• Managed project documentation using Jira for issue tracking and progress monitoring.
• Employed Jama for requirements management to ensure traceability and clarity.
• Created test data for validating scenarios based on functional requirements.
• Reviewed all supplier requests for deviation from specifications and approved or denied changes.
• Wrote, revised and maintained documentation outlining standard test procedures and automation standards for reference throughout testing department.

• Designed and developed frames for 30ft, 35ft, 40ft, and 45ft flex draper products from concept to production.
• Collaborated with manufacturing, quality, and FEA teams to address design challenges.
• Created detailed CAD drawings and 3D models for mechanical components and assemblies.
• Streamlined workflows from design to manufacturing, reducing time to market for new products.
• Conducted research to evaluate equipment feasibility and performance metrics.
• Developed mechanical designs for new products while modifying existing designs to meet customer needs.
• Utilized software and computer-assisted drafting tools to enhance structural product design.
• Produced 2D drawings adhering to GD&T standards.

• Executed conversion and migration of datasets from Catia V4 to Catia V5.
• Developed detailed CAD drawings and 3D models for mechanical components and assemblies.
• Created drawings for parts and assemblies to support project requirements.
• Delegated tasks effectively, ensuring quality control across projects.
• Analyzed data, leading to recommendations that prompted adoption of new cost-saving equipment.