Quality Engineer · Class III implants

Shubhankar Gouraj

I work on quality for implantable medical devices, from first article inspection and supplier corrective actions to the device history record that ships with every unit.

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Devices

What I've helped build and ship.

Implants, wearables and surgical tools I've inspected, tested, documented or designed. Drag or flick to browse.

VNS implant · Class IIIMilo

Vagus nerve stimulator

Quality inspections, test support, DHF review and DHR upkeep, SCARs for critical components, SolidWorks drawings for design control.

Teliatry Inc. · 2023 to now
Optical sensingNIRS

Near-infrared spectroscopy

First article inspections, manufacturing process development with operations, and design control drawings.

Teliatry Inc. · 2023 to now
Vital monitoringAVM

Acute vital monitor

Built out the manufacturing process and drove supplier corrective actions to close non-conformances.

Teliatry Inc. · 2023 to now
Vital monitoringCVM

Chronic vital monitor

Quality inspections and testing support against ISO 9001 and ISO 13485 requirements.

Teliatry Inc. · 2023 to now
VNS implantIPG

ReStore pulse generator

Functional testing of the implantable pulse generator, AQL-based inspections and a defect repository for the program.

TxBDC, UT Dallas · 2022 to 2023
WearablePCM

ReStore power & comms module

Supported manufacturing and testing, wrote purchasing specs, ECNs and work instructions.

TxBDC, UT Dallas · 2022 to 2023
Surgical toolScope

Endoscope stabilizer

Designed with surgeons after observing live procedures, to make endoscopic work steadier in the OR.

Dr. Khan's Creation, Pune · 2020
Prosthetic · FDMHand

3D-printed prosthetic hand

Modeled in SolidWorks, printed in FDM and fitted with electronics to mimic natural hand movement.

Think3D, Visakhapatnam · 2019
Experience

Where I've worked.

  1. Jun 2023 to present
    Current

    Quality Engineer

    Teliatry Inc. · Texas

    • Run quality inspections and support testing for Milo (VNS implant), NIRS, AVM and CVM, in line with ISO 9001 and ISO 13485.
    • Develop manufacturing processes with the operations team for NIRS, Milo and AVM.
    • Review Design History Files with R&D and maintain Device History Records across projects.
    • Manage Supplier Corrective Action Reports for critical components, closing non-conformances and lifting supplier performance.
    • Produce engineering drawings and specifications in SolidWorks to support design control.
  2. Feb 2023 to May 2023

    Quality Intern

    Teliatry Inc. · Texas

    • Assisted with inspections and First Article Inspections for the NIRS project.
    • Documented and helped resolve Non-Conformance Reports.
    • Organized DHRs and DHFs, and kept inventory and the Approved Supplier List current.
  3. Mar 2022 to Mar 2023

    Student Volunteer

    Texas Biomedical Device Center (TxBDC), UT Dallas

    • Inspected ReStore VNS components to AQL standards and built a defect repository.
    • Supported manufacturing and testing of the wearable ReStore PCM.
    • Wrote purchasing specifications, ECNs and work instructions; ran functional tests on the ReStore IPG.
  4. Jan 2020 to Jul 2020

    Design Intern

    Dr. Khan's Creation · Pune, India

    • Designed an endoscope stabilizing device with surgeons to improve procedural efficiency.
    • Attended live surgeries to find the clinical problems worth solving.
  5. Jun 2019 to Aug 2019

    Design Intern

    Think3D, Kalam Institute of Health Technology · Visakhapatnam, India

    • Designed and FDM-printed a functional prosthetic hand in SolidWorks, with electronics for natural movement.
Skills & credentials

The toolkit.

Skills

Risk & compliance

FMEARisk managementCAPANon-conformances

QMS & audits

ISO 13485Internal auditsProtocols & reportsDHF / DHRAQL sampling

Process & design

Six SigmaSolidWorks3D printing (FDM, SLA)Work instructions

Working style

Cross-functional teamsProject managementNegotiationDetail-oriented

Education

M.S. Biomedical EngineeringThe University of Texas at Dallas
Aug 2021 to May 2023
Integrated M.Tech. BioengineeringMIT School of Bioengineering Sciences and Research, Maharashtra
Aug 2016 to Jul 2021

Certifications & publication

ISO
ISO 13485:2016 QMS AuditorMedical devices quality management systems
CAD
SolidWorksCertified
PUB
Surface-modified paper-based colorimetric sensor using synthesized Ag NPs-alginate compositeSharma, Gouraj, Raut, Tagad · Environmental Technology, Taylor & Francis
Contact

Let's build devices people can trust.

Whether it's a quality engineering role, an audit, or a device that needs a careful second look, I'd be glad to hear from you.

  • Emailgouraj95@gmail.com
  • Based inMcKinney, TexasDallas–Fort Worth · Central Time