Nithya Raikar
Summary
A professional with over 15 years of experience and a strong background in sterilization validation and regulatory compliance. Proven track record in leading and managing successful product lifecycle management, and recognized for excellence in organization. Demonstrate a positive approach and strong leadership in cross-functional teams. Active SWE member and mentor.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Principal Scientist
Mozarc Medical
01.2024 - Current
- Leading the sterilization of renal access products at Mozarc Medical.
- Responsible for managing the characterization, validations of sterilization, and microbiological testing as per the standard requirements: ISO 11135, ISO 11737, EN 556-1, ISO 17665-1, ISO 10993-7, ISO 60601-2, and ISO 13485.
- Active participant as a sterilization SME for audits (FDA, EU-MDR, and TUV).
- Works collaboratively with cross-functional teams across the globe, and sterilization contract manufacturers.
- Experienced in product lifecycle from R&D to clinical phase.
- Green Belt certified in DRM (Design, Reliability, and Manufacturing)
- Active SWE member and mentor. Lead WISE (Women in Science and Engineering, India)
Principal Scientist
Medtronic
03.2017 - 12.2023
- Manager - Chemistry/Biolab Department with a team size of 9.
- Lead sterilization of renal access products (ISO 11135, ISO 11737, EN 556-1, ISO 10993-7, IEC 60601-2).
- Characterization and development of the disinfection process in sorbent cartridges (Product lifecycle) - Successful process development and awarded the Quarterly Best Employee Award.
- Microbiological test method validation as per USP 85 and USP 61.
- Green belt certified in Design, Reliability, and Manufacturing (DRM)
- Active SWE member and mentor, presented at SWE conferences. Lead WISE (Women in Science and Engineering, India)
Research Scientist
Richcore Lifesciences
06.2011 - 03.2016
- Analytical Research in R&D.
- Characterization and development of enzymes for the STP water plant.
- Involved actively in the product lifecycle of the development of Ecosol (microbial sewage water treatment plant).
- Involved in protein purification (downstream processing) – trypsin.
Researcher
Central Food Technological Research Institute, Mysore
05.2010 - 04.2011
- Isolation of food pathogens from different food sources.
- DNA purification of Listeria monocytogenes species.
Education
M.Tech - Biotechnology
Karunya University
Coimbatore05-2011
B.Tech - Biotechnology
Karunya University
Coimbatore04-2009
Skills
- Sterilization validation
- Regulatory standards compliance
- Water purification systems
- Microbiological testing
- Product lifecycle management
- Technical documentation
- Positive approach
Affiliations
Entrepreneur and influencer
Languages
Tamil
First Language
English
Advanced (C1)
C1
kannada
Intermediate (B1)
B1
Accomplishments
- Honored with a cash prize for the successful demonstration of a water purification system with a low cost and less weight at Karunya University in 2009
- International journal publication on nanomaterials extracted from plants
- Employee award in 2018 at Medtronic
Certification
- DRM green belt certified at Medtronic in 2021
- Industrial sterilization certified by AAMI in 2022
- Ethylene oxide sterilization certification from AAMI in 2023
Timeline
Principal Scientist
Mozarc Medical
01.2024 - Current
Principal Scientist
Medtronic
03.2017 - 12.2023
Research Scientist
Richcore Lifesciences
06.2011 - 03.2016
Researcher
Central Food Technological Research Institute, Mysore
05.2010 - 04.2011
M.Tech - Biotechnology
Karunya University
B.Tech - Biotechnology
Karunya University
Similar Profiles
Mercedes Schultz M.D.Mercedes Schultz M.D.
Hospital Employed Ob/GYN Physician at Memorial Medical Clinic/Memorial Medical Center, Medical ClinicHospital Employed Ob/GYN Physician at Memorial Medical Clinic/Memorial Medical Center, Medical Clinic
JOANNA SETTERBERGJOANNA SETTERBERG
Senior IT Director at Medical City Dallas & Medical City Heart & SpineSenior IT Director at Medical City Dallas & Medical City Heart & Spine
Brenda ZamoraBrenda Zamora
Nurse Assistant (registry) at West L.A VA Medical Center(westways Medical Staff)Nurse Assistant (registry) at West L.A VA Medical Center(westways Medical Staff)