Careers in MedTech

Surabhi Ramesh Experienced Medical Device Engineer (System Engineering, Design Assurance, Device Development)
  • May 20, 2019
  • Software and Hardware Design Assurance Engineering of a catheter based renal denervation therapy device
  • Systems Functional Engineering of a minimally invasive robotic surgery - Einstein platform
  • 2+ years of product development and quality engineering experience
  • Developed an ECG monitoring device to detect arrhythmia; also implemented fiber photometry imaging to study neural circuits underlying performance evaluation in animal model
  • 1+ years of in-vivo and in-vitro laboratory experience in experimental design, data processing and analysis
  • Hands on experience with neurophysiology and cardiac electrophysiology measurements using LabVIEW and MATLAB
  • Experience in working on projects related to developing algorithms for biomedical image (CT, MRI, OCT) and signal processing using MATLAB
  • Experience working with JAMA requirements management tool
  • Familiarity with Quality Management System Regulations for Medical Devices - Good Manufacturing Practice Regulation, Good Clinical Practices and FDA quality system regulations
  • Experience working on statistical methodologies, quality control and manufacturing tools, such as Minitab, ANOVA, Lean, Six Sigma, CAPA, FMEA etc.
  • Outstanding knowledge of Verification and Validation protocols
  • Experience managing cross-functional teams spread across continents and project management

Technical skills:      C, C++, MATLAB, LabVIEW, Minitab, Visio, Enterprise Architect, Microsoft Word, Microsoft Excel

       Laboratory skills:   Research, Data acquisition, Analysis, Troubleshooting, Debugging, and Technical writing

Industry skills:        ISO 13485, IEC 60601, 21 CFR Part 820, FMEA, Six Sigma, Design, Reliability & Manufacturability

Category
Medtech
E-mail
sr996@cornell.edu
Phone Number
6076973481

Education

Masters in Biomedical Engineering @ Cornell University
Aug 2016 — May 2017
Specialization in Medical Device development
Bachelor of Engineering @ SJCE , India
Sep 2010 — Jun 2014
Major in Electronics and Instrumentation Technology

Experience

Hardware/Software Design Assurance Engineer @ Medtronic
Nov 2018 — Current
Catheter based Renal Denervation therapy for treating hypertension

• Perform hardware and software verification and validation testing on catheter and generator component of a renal denervation medical device
• Develop and conduct technical evaluation of engineering design concepts and generate technical reports
• Conduct risk analysis studies such as Failure Mode Effect Analysis (FMEA) for software, hardware design and usability of the device
• Create quality owned deliverables in product development in biomedical engineering of the device
• Trained on Medtronic Design, Reliability & Manufacturability green belt methodologies on integrating best practices into project
Associate R&D Engineer @ Medtronic
Mar 2018 — Oct 2018
Minimally invasive robotic surgery – Einstein platform

• Designed sequence diagrams to address case scenarios at system software architectural level
• Collaborated with cross functional engineers to refine system requirements definition and specification
• Worked with systems integration and test teams to review software verification protocols and test reports
Research technician @ Cornell University - Goldberg Lab
Jul 2017 — Dec 2017
• Implemented fiber photometry imaging technique to detect brain circuits underlying motor learning in mice
• Developed LabVIEW, MATLAB and Minitab scripts for processing data and handling poor signal-to-noise ratio
• Implemented pre-processing hardware and software for signal conditioning
Graduate student researcher @ Cornell University - Adie Lab
Aug 2016 — May 2017
• Performed image-guided investigation of mechanical properties of collagen protein for early diagnosis of skin cancer using in vivo imaging modality Optical Coherence Elastography (OCE)
• Programmed LabVIEW software to acquire images of healthy and cancer tissues
• Analyzed spectroscopic results of OCE using MATLAB and Minitab
Associate Software Engineer @ Ernst & Young
Jul 2014 — Oct 2015
• Trained on agile model of software development processes
• Generated software requirements, software design, and test documentation
• Established lean six sigma control methodologies for process and operation improvement
Quality Engineering Intern @ Larsen & Toubro Medical Sytems
Jun 2013 — Aug 2013
• Exposure to verification and validation procedures (IQ, OQ, PQ) in medical device development
• Performed root cause analyses on process and product development failures
• Documented FDA design control and human factors guidance standards, processes, and protocols
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