Shruthi Mohan Email & Phone Number

Bengaluru, Ka, In

Waukegan, Il, Us

Minneapolis, Minnesota, Us

• Developed comprehensive Master Validation Plans and oversaw validation activities including PFMEA, GRR, TMV, IQ, OQ, and PQ, enhancing product quality and compliance.• Increased production capacity through capital expense requests of about $1 million.• Implemented sync flow principles, optimizing takt time and improving workflow performance, resulting in significant increase in operational efficiency.• Drove automation initiatives to reduce labor content and skill required for the operation.• Conceptualized technology implementation to reduce adhesive application defects and reprocessing. • Developed, characterized, and optimized catheter manufacturing processes using DOE methodologies, exceeding customer specifications.• Implemented improvements leading to a 25% decrease in process defects and enhanced product quality.• Orchestrated seamless operations between company sites, showcasing leadership in diverse scenarios.• Ensured compliance with FDA and ISO standards, facilitating accurate documentation and implementation of validation protocols.• Utilized Fishbone analysis and five why's to drive root cause investigations and implement corrective actions. • Conducted value stream mapping and optimized workflow, reducing cycle time and improving process quality.

Minneapolis, Minnesota, Us

Product Innovation and Design:• Collaborating with physicians in a clinical environment to identify user needs and requirements• Assessing needs and understanding business and customer requirements by analyzing competitors, existing market and patent landscape to develop the design inputs• Mapping value streams and existing process by developing flowcharts and defining key performance indicators to assess quality and reliability• Conducting risk analysis using FMEA.• Identifying root cause using fish bone analysis and implementing corrective actions• Using process data analysis to implement DMAIC, Six Sigma, and Lean technologies to improve the process

Testing and Validation:• Implemented rigorous bench-top testing, Repeatability and Reproducibility studies to validate the medical device and implemented IQ, OQ, PQ protocols• Performed material testing and inspection according to the sampling plan• Implemented process verification and validation protocols after production data analysis and assessed risks using PFMEA• Quality Management• Maintained documentation of Device Master Record including device drawings with appropriate Geometric Dimentioning and Tolerancing for design transfer to manufacturing• Tracked the completion and organization of documents: SOP, Training, Quality Assurance, Quality Control Plan, Material Inspection, Change control by following Good Documentation Practices• Conducted Internal audits across various departments to identify nonconformances.• Performed root cause analysis and implemented CAPA plan reducing production department nonconformities by 70 percent• Represented the Production department at the ISO 9001: 2016 Audit.

Master’S Degree, Applied Bioengineering

Bachelor’S Degree, Biomedical/Medical Engineering

High School