# Nr Koka Nr Koka is a remote worker on Himalayas, Founder / Design Quality Engineer & AI App Builder at Tyche, LLC, based in United States. Source: https://himalayas.app/@nrkoka ```text Design Quality Engineer at Tyche, LLC who built an AI-powered medical-device compliance auditing platform. ``` | Detail | Value | | --- | --- | | Availability | Looking for a job | | Location | United States | | Authorized to work in | United States | | Salary expectations | 160k+ USD | | Job categories | Software Quality Engineer, Software Quality Engineer, Design Assurance Engineering, Quality Engineer, Project Manager, QA Manager | | Skills | Design Control, Software Quality Engineering, Design Assurance, Quality Systems, Software as a Medical Device (SaMD), Risk Management, CAPA, Complaint Management, Design Verification, Design Validation, Software Testing, Requirement Traceability, Regulatory Compliance, IEC 62304 (SDLC), IEC 82304 | | Website | https://meddeviceaudit.com | ## About ```text At Tyche, LLC, I founded and built MedDeviceAudit, an AI-powered SaaS compliance auditing platform for Class II medical devices. It applies IEC 62304 software lifecycle controls, FDA QMSR 2026, ISO 13485:2016, and ISO 14971 requirements. I designed its 9P/2G Evidence Engine with SHA-256 evidence anchors to evaluate software, firmware, and system-level design artifacts against regulatory intent. The audit logic addresses SaMD classification, test traceability, hardware-software interface risks, and design verification gaps. At Abiomed, I supported development and quality activities for Impella heart pumps and AIC software, and worked as Quality Lead on the Impella Connect SaMD platform using Azure cloud. At Elsevier, I supported Design History File artifacts and worked as Quality Lead on the Elsevier app, also using Azure cloud. Across medical-device and software work at companies including IntegraLife, Baxter Healthcare, and Rockwell Automation, I have contributed to design controls, risk management, verification and validation, complaint/CAPA work, and project delivery. My experience includes SaMD and cloud software as well as quality-system and regulatory requirements. ``` ## Experience ### Founder / Design Quality Engineer & AI App Builder (current) Tyche, LLC. Jan 2025 - Present ```text Founded and built MedDeviceAudit, an AI-powered SaaS compliance auditing platform for Class II medical devices, implementing IEC 62304, FDA QMSR 2026, ISO 13485:2016, and ISO 14971 requirements. Architected the platform's 9P/2G Evidence Engine with SHA-256 evidence anchors to evaluate design artifacts against regulatory intent. ``` Skills: IEC-62304-(SDLC), FDA-QMSR-2026, ISO-13485, ISO-14971, AI, SaaS, ChatGPT-4o, Claude-3.7-Sonnet, Gemini-2.5-Flash, Replit, Supabase, SHA-256, Risk-Management, Design-Control ### Sr. Software Quality / Design Assurance Engineer [Abiomed](https://himalayas.app/companies/6942-abiomed-inc-legal-entity). Nov 2022 - Jan 2025 ```text Supported products throughout all development phases, test protocol development, and process qualification/validation for Impella heart pumps and AIC software. Participated in risk management and worked as Quality Lead on Impella Connect platform (SaMD) using Azure cloud. ``` Skills: software-quality, Design-Assurance, Test-Protocols, Risk-Management, Azure, SaMD, Impella, AIC ### Sr. Design Assurance Engineer IntegraLife. Jun 2021 - Oct 2022 ```text Reviewed MDD technical files, identified compliance gaps, and performed mitigation for MDR submissions. Developed and managed Design Control processes compliant with FDA QSR, EU-MDR, and ISO 13485. ``` Skills: MDD, MDR, CE-Technical-Files, Design-Control, FDA-QSR, EU-MDR, ISO-13485, Risk-Management ### Software Quality Engineer [Elsevier](https://himalayas.app/companies/elsevier). Feb 2022 - May 2022 ```text Ensured QMS artifacts related to the Design History File were generated at the right level of detail. Reviewed design verification and validation, created traceability, participated in design reviews, and worked as Quality Lead on Elsevier app (SaMD) using Azure cloud. ``` Skills: QMS, Design-History-File-(DHF), Design-Verification, Design-Validation, Traceability, Design-Reviews, SaMD, Azure ### Project Manager Cirtec Medical. Feb 2020 - Sep 2020 ```text Managed and coordinated design and development of complex Class II and Class III medical devices. Generated and maintained project plans, task lists, and risk registers, and coordinated activities across functional groups. ``` Skills: Project-Management, Medical-Devices, Class-II, Class-III, Risk-Register, Cross-functional-Coordination ### Sr. Design Assurance Engineer [Bausch & Lomb](https://himalayas.app/companies/bausch-lomb-gmbh). Jan 2019 - Dec 2019 ```text Joined Eye Surgical Project team to execute strategic objectives and complete projects. Worked on secured eyeTELLIGENCE application (SaMD) on IBM Cloud, and developed planning documents, engineering studies, and design verification for product enhancements. ``` Skills: Design-Assurance, SaMD, IBM-Cloud, Design-Control, Risk-Management, CAPA, EyeTELLIGENCE ### Sr. Quality Engineer Bio Telemetry. May 2018 - Dec 2018 ```text Ensured compliance to design change procedures and global regulations, and directed all phases of Complaint/CAPA projects. Collaborated to ensure safety and availability of remote cardiac monitoring devices, reducing complaint rates. ``` Skills: CAPA, Complaint-Management, FDA-QSR, ISO-13485, Cardiac-Monitoring, Compliance ### Project Manager Tyche, LLC. Aug 2016 - May 2018 ```text Worked with project team through end-to-end development lifecycle for a social website using agile methodology. Participated in estimating, planning, and management, and supervised offshore team. ``` Skills: Agile, Project-Management, Estimating, Planning, Team-Leadership, Offshore-Management ### Sr. Design Assurance Engr. [Baxter Healthcare](https://himalayas.app/companies/baxter-international-inc). Nov 2013 - Aug 2016 ```text Provided support to two dialysis products (Claria and Vivia) across multiple business functions. Served as Quality Lead for Sharesource Cloud Infrastructure Project (SaMD) and data migration, and supported post-market surveillance reviews. ``` Skills: Design-Assurance, Dialysis-Products, SaMD, Cloud-Infrastructure, Data-Migration, Post-Market-Surveillance, Quality-Systems ### QA Manager [Rockwell Automation](https://himalayas.app/companies/rockwell-automation). Apr 2010 - Oct 2013 ```text Managed offshore team of 2 QA testers, testing full lifecycle for a $25M project. Wrote and reviewed test cases and documents, oversaw functional and regression testing, and developed 'SCT in the Cloud' project using Windows Azure. ``` Skills: QA-Management, Test-Planning, Test-Case-Design, Regression-Testing, Azure, Offshore-Team-Management ### Sr. Software Quality Engineer [GE Healthcare](https://himalayas.app/companies/ge-healthcare). Jul 2008 - Mar 2010 ```text Oversaw data validation processes for applications and technology within Invasive Cardiology Division. Orchestrated software reliability planning, execution, and tracking, and formulated verification plans and traceability matrices. ``` Skills: Data-Validation, Software-Reliability, Software-Verification-Plans, Requirements-Traceability-Matrix, Interventional-Cardiology ### Sr. Principal Engineer (Software/Systems) [Baxter Healthcare, Inc.](https://himalayas.app/companies/baxter-international-inc). Mar 2006 - Dec 2007 ```text Oversaw software, systems, and service engineering under Transfusion Therapeutics Division. Managed 22 onshore and offshore staff, drove successful testing and implementation of 4 software releases, and streamlined approval process. ``` Skills: Software-Engineering, Systems-Engineering, Team-Management, Testing, Validation, Release-Management ## Education ### University of Iowa Master of Science, Electrical and Computer Engineering ```text Master of Science in Electrical and Computer Engineering from the University of Iowa. ``` ### Osmania University Bachelor of Engineering, Electronics and Communication Engineering ```text Bachelor of Engineering in Electronics and Communication Engineering from Osmania University. ``` ## Tech stack - Oracle - .NET - Java - PHP - C++ - C - Windows 10 - Microsoft Excel - FitNesse - SAP - IBM Cloud - Silk Performer - Supabase - Microsoft Word - Replit - Microsoft PowerPoint To contact Nr, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire). ## People also viewed - [Susan Trinh](https://himalayas.app/@susantrinh): Technical Program Manager, Boston Scientific - [Zhanna Tukin](https://himalayas.app/@zhannatukin): Software Engineer, CriTech Research LLC - [BRIAN JOHNSON](https://himalayas.app/@brianjohnson3): Quality and Regulatory Specialist, Matrix Requirements - [Timothy Cowart](https://himalayas.app/@timothycowart): Project Manager, Koning Corporation - [bhargavi kannan](https://himalayas.app/@bhargavikannan): QA & Regulatory Affairs Intern, Micro Medical Devices - [Ali Zhian](https://himalayas.app/@alizhian): Supplier Quality Engineer II, Boston Scientific - [Thomas Barrett](https://himalayas.app/@thomasbarrett): Senior QA Consultant, IonSQA - [Lauren DesJardins](https://himalayas.app/@laurendesjardins): Engineering Product Manager, Vaporox - [Bhavani Jayachandran](https://himalayas.app/@bhavanijayachandran): Senior Principal Systems Engineer, Baxter - [Ryan Brownewell](https://himalayas.app/@ryanbrownewell): Engineering Manager, MedRhythms