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.

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

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

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 aide for the biomechanics lab.

Tools: Simscape (Simulink and Matlab) on a mechanical knee