# Abhinaya Srikanth

> Technical Program Manager at Meraqi Viant Medical

Location: San Francisco Bay Area, United States
Profile: https://flows.cv/abhinaya

Technical Program Manager with 6 years of experience in the medical device industry with a background as a product development engineer. I specialize in leading cross-functional teams to deliver innovative class II and class III devices, ensuring they meet regulatory standards and market needs. With 5 years of experience managing and leading teams, my expertize lie in project management, strategic planning. customer engagement , driving complex high business value project through its various phases of the product life cycle while aligning with business goals and compliance requirements.

## Work Experience
### Program Manager @ Viant Medical
Jan 2023 – Present | San Francisco Bay Area
Managed an interdisciplinary team through the development of the implantable leaded design by applying design controls , project management and resource management.
∙ Led an interdisciplinary team through time-sensitive FIH (First in human) clinical builds through agile work practices and schedule-driven Project Management practices.
∙ Led the team through Pre-clinical and animal validation.
∙ Drafted Hazard Analysis, and risk management reports incorporated into design Inputs and
outputs.
∙ Managed budget resources for a time-sensitive project.
.Conducted impact assessment and feasibility analysis as part of change management.
∙ Drafted project documents like project plans, PHF and DHF.
∙ Recruited, mentored and developed a training plan for new hires of the design team.
∙ Actively collaborated with the leadership and management team to identify operational bottlenecks and inefficiencies.

### Technical Project Manager @ Viant Medical
Jan 2022 – Jan 2024 | San Francisco Bay Area
For classIII implantable leads
∙ Managed an interdisciplinary team of Engineering, quality, systems engineers and regulatory through setting up and testing of Design verification against ISO 14708, and ISO 60601 testing.
∙ Spearheaded Design review meetings with the leadership team ,key stakeholders and the business unit. ∙ Developed Risk management reports,hazard analysis and FMEA reports.
∙ Conducted regression analysis on device configuration changes.
Development and support through Canadian Special Access Program for a Micro Angioscope Design.
∙ Led an interdisciplinary team including senior management, customers and suppliers in formulating a strategic plan for the seamless execution of builds through testing, and timely release of clinical units for the time-sensitive SAP program.
∙ Managed an interdisciplinary team to conduct design verification testing,
∙ Drafted Project Proposal and Quality Plan and maintained resource and budget tracking.
∙ Maintained constant communication with customers and key stakeholders regarding project milestones, resources and
budget.
For a classII balloon Guide Catheter (Neuro application)
∙ Collaborated closely with the quality and regulatory team to develop and draft Test protocols and reports per ISO10555, ISO 10993-1 and AAMI TIR42:2021 to support FDA 510 K application.
∙ Led the team in implementing process and design enhancements, resulting in increased vertical lamination yield by optimizing parameters, introducing process aids, and bolstering confidence through the performance of characterization tests

### Product Development Engineer II @ Viant Medical
Jan 2019 – Jan 2022 | San Francisco Bay Area
Guided a team through multiple Design Verification (DV) and Pre-DV activities, overseeing the development of test protocols, successful test execution, and the subsequent creation of comprehensive DV reports per ISO 10555 ∙ Executed Design FMEA ,performed comprehensive data analysis on diverse Design Verification (DV) datasets (comparing aged non
aged date, Tensile, balloon compliance and inflation deflation data) utilizing statistical models through MATLAB and Minitab
∙ Performed testing setup and executed particulate testing sample collection per ISO 10993-1, AAMI TIR 42:2021 ∙ Designed fixture and process for filtration and collection of purified water of size 0.2 micron, 0.8 micron for particulate validation
testing.
∙ Led the design team, ensuring the successful completion of Health CANADA (CMDR) submissions, resulting in acceptance of a
class II Balloon Guide Catheter design for stroke applications.
Manufacturing:
∙ Supported in developing a manufacturing process, drafted process documents, costed BOM, and designing and developing fixtures to enhance manufacturing flow and efficiency. Designed fixtures using SOLIDWORKS for balloon bonding, coating, lamination, as well as the nitinol coil process.
∙ Provided mentorship to new engineers, guiding them in equipment qualifications and implementing diverse process improvements, while also managing effective communication with vendors to ensure seamless collaboration and project success.
∙ Guided the team in exploring streamlined hydrophilic coating processes and plasma treatment options to find the best fit for the product. Conducted substrate analysis, characterization studies, and benchtop trials, resulting in a 20% improvement in coating yield
∙Supported a team in execution of clinical (FIH) builds by exercising clinical readiness activities and lot release test planning and execution.
∙Conducted equipment OQ PQ validation plans

### R&D/Product Development Engineer II @ AdvancedCath, now TE Connectivity
Jan 2019 – Jan 2021 | san jose
Create new design solutions /manage device builds from R&D prototype stage up to production for minimally invasive cardio and neuro catheters and localization devices. 
Develop fixtures using SOLIDWORKS to support product builds.
Conduct FMEA (Failure Mode Effects Analysis) and risk analysis reviews on NPI (New Product Introduction). 
Draft process instructions (MPI) and supporting documents.
Support and oversee builds inside the Control Environment Room.

### Research Assistant @ San Jose State University
Jan 2018 – Jan 2019 | San Jose, California, United States
Research aide for the biomechanics lab.
Tools: Simscape (Simulink and Matlab) on a mechanical knee

### Radiation Specialist /validation engineer @ Steri-Tek
Jan 2018 – Jan 2019 | Fremont, California, United States
Product Radiation Dose Mapping, analyze dose mapping data to understand medical sterilization using X-ray, Gamma and E-beam radiation, Dose Map Verification, and R&D studies.

### Biomedical Device Engineer @ ArjoHuntleigh GETINGE GROUP
Jan 2015 – Jan 2016 | Mumbai Area, India
1) Conducted  servicing of pressure pumps for DVT systems, fetal monitors, ventilators and medical beds.
2)Conducted quality and track-wise checks.
3)Provided technical, clinical and product support for medical devices.


## Education
### Master's degree in Biomedical/Medical Engineering
San José State University

### Bachelor's degree in Biomedical/Medical Engineering
Padmashree Dr. D.Y.Patil University


## Contact & Social
- LinkedIn: https://linkedin.com/in/abhinayasrikanth

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Source: https://flows.cv/abhinaya
JSON Resume: https://flows.cv/abhinaya/resume.json
Last updated: 2026-04-13