HARSHITHA N
Bangalore
Summary
Results-driven Manufacturing Engineer with over 7 years of experience in the healthcare and medical device industry. Proven expertise in process optimization, quality assurance, and cross-functional collaboration. Adapt at developing efficient manufacturing processes, ensuring regulatory compliance, and driving continuous improvement. Recognized for strong analytical thinking, leadership, and commitment to product safety and quality.
Overview
9
9
years of professional experience
Work History
Manufacturing Process Engineer
GE Healthcare
Bangalore
03.2022 - Current
- Developed and optimized manufacturing processes for Ultrasound product lines under design transfer programs.
- Created and maintained SOPs and work instructions aligned with QMS standards.
- Trained production operators on new processes and equipment, ensuring adherence to best practices.
- Collaborated with cross-functional teams to design efficient production lines and workstations.
- Participated in design reviews to enhance manufacturability and cost-effectiveness.
- Investigated and resolved production issues, implementing corrective actions to prevent recurrence.
Operation Specialist
GE Healthcare
Bangalore
03.2018 - 02.2022
- Conducted mandatory QA tests post-installation of XR-based equipment as per AERB norms.
- Managed e-LORA portal submissions for QA reports and site layouts to facilitate licensing.
- Contributed to process improvement projects for e-LORA licensing and Q-Serve digitalization.
- Resolved customer issues related to licensing and procurement permissions.
- Led initiatives to digitize QA reports, improving accuracy and reducing manual intervention.
Biomedical Engineer
Apollo Hospital
Bangalore
05.2017 - 03.2018
- Trained clinicians on the use of biomedical equipment and ensured proper installation.
- Oversaw system testing and validation to meet performance and safety standards.
- Developed and implemented design and development procedures.
- Maintained professional relationships with clinicians and scientific advisors.
Education
Bachelor of Engineering - Medical Electronics
Dr. Ambedkar Institute of Technology
01.2015
PUC - PCMB
KLE Independent PU College
01.2011
SSLC -
Cambridge High School
01.2009
Skills
- Process Engineering
- Design Transfer
- SOP & Work Instruction Development
- Project Management
- Cross-functional Collaboration
- Root Cause Analysis
- Regulatory Compliance
- E-LORA Licensing
- Technical Documentation
- Operator Training
- MS Excel
- Word
- PowerPoint
Languages
- Kannada (Regional)
- English
Personal Information
- Date of Birth: 05/22/93
- Marital Status: Single
Timeline
Manufacturing Process Engineer
GE Healthcare
03.2022 - Current
Operation Specialist
GE Healthcare
03.2018 - 02.2022
Biomedical Engineer
Apollo Hospital
05.2017 - 03.2018
Bachelor of Engineering - Medical Electronics
Dr. Ambedkar Institute of Technology
PUC - PCMB
KLE Independent PU College
SSLC -
Cambridge High School