Nishanth is available for hire
Hire NishanthNishanth Muppala
Verified Expert in Engineering
Safety Management Engineer and Quality Developer
Espoo, Uusimaa, Finland
Toptal member since April 18, 2023
Bio
Nishanth is a seasoned quality and safety management professional with 13+ years of experience in integrated management systems, process consulting, and technical expertise in systems, software, risk, requirements, and supplier management. He is a certified Functional Safety Engineer and Quality Management Systems Auditor. Nishanth specializes in parts 2, 3, 4, 6, 8, and 9 of ISO 26262 and has extensive experience in gap analysis, process definition, and life-critical product implementation.
Portfolio
Sensible 4
ISO 26262, ISO 9001, Automotive SPICE, Audits, Reviews, Systems Engineering
ESE
Functional Safety, Automotive SPICE, Requirement Traceability Matrices...
GalaxE
Audits, ISO 13485, FDA, CFR Title 21 Part 11, 21 CFR Part 820, MDR, ISO 14971...
Experience
- Audits - 13 years
- Reviews - 13 years
- ISO 9001 - 13 years
- Automotive SPICE - 11 years
- IBM ALM - 8 years
- DOORS - 7 years
- ISO 26262 - 6 years
- Systems Engineering - 3 years
Availability
Part-time
Preferred Environment
Windows, Jira, IBM ALM, DOORS
The most amazing...
...thing I've developed was the automation of the metrics derivation process, which saved 200 man-hours per week.
Work Experience
Functional Safety Manager
2020 - PRESENT
Sensible 4
- Established the organization's systems engineering practices, defined an integrated management system based on ISO 26262, ISO 9001, and ASPICE, and provided training to develop a culture of safety.
- Derived item definition, performed functional analysis and HARA to derive safety goals, participated in FSC and TSC derivation, and performed safety analysis across development. Conducted confirmation reviews and audits and prepared the safety plan.
- Introduced a hybrid development methodology based on the V model and Scrum methodology, including the industry best practices, and ensured traceability across the documentation, RCA, and CAPA for non-conformities and process improvement.
- Improved the processes based on performance analysis and held workshops in the external environment to strengthen the safety culture by taking real-world scenarios of life-critical products as examples.
- Trained resources on system engineering practices, requirements management, risk management, configuration, change management, problem resolution, issue management, and AUTOSAR methods. In addition, trained in the use of tools and created guidelines.
- Participated in the establishment of a customer-centric approach to processes, contributed to the development of internal and external Development Interface Agreements (DIA), and created presales processes and estimation methods.
- Delivered a verification and validation plan based on ISO 26262, ISO 21448, and ISO 22737 to ensure the implementation of the verification and validation (V&V) practices and participated in fault injection tests.
- Developed a concept of operations (CONOPS) to support item definition and provide a high-level use case and intended use of the ADS. Additionally, I assisted in the preparation of use cases and ODD to facilitate functional analysis and HARA.
- Supported the GitLab migration, provided guidelines and instructions to ease the migration, and accomplished the migration task in two weeks with appropriate measures, support, and monitoring.
Technologies: ISO 26262, ISO 9001, Automotive SPICE, Audits, Reviews, Systems Engineering
Functional Safety Engineer | Trainee Assessor
2020 - 2020
ESE
- Created an integrated management system by defining tool-based processes, guidelines, checklists, templates, and tools.
- Participated in item definition, items functional analysis, and HARA to derive safety goals.
- Conducted safety reviews and participated in FSC and TSC preparation.
- Provided confirmation measures such as work product reviews, audits, and assessments.
Technologies: Functional Safety, Automotive SPICE, Requirement Traceability Matrices, Process Definition
Lead Process Consultant
2018 - 2019
GalaxE
- Conducted application and device risk assessment to define requirements for controls and executed test cases to ensure the implementation of controls.
- Guaranteed compliance with the 21 CFR 11 regulation related to electronic signatures and document liability.
- Performed work product reviews, compliance checks, audits, and stage gate assessments to ensure project integrity.
- Prepared the validation plan and validation summary report.
Technologies: Audits, ISO 13485, FDA, CFR Title 21 Part 11, 21 CFR Part 820, MDR, ISO 14971, IEC 62304
PMG Lead
2016 - 2018
ValueLabs
- Defined and implemented processes across all projects to comply with customer requirements.
- Participated in the Development Interface Agreement (DIA), project management support, customer reviews and audits, and monthly presentation of project status data to the customer.
- Conducted safety analyses during software development and participated in confirmation reviews and audits.
- Provided support in automating Jira metrics data on projects, which reduced resource efforts on documentation.
Technologies: Automotive SPICE, ISO 26262, Audits
Senior Process Consultant
2014 - 2016
KPIT
- Provided tailored guidance in establishing the Development Interface Agreement (DIA) with the stakeholders, based on proper rationale and justification, to ensure that functional safety requirements did not deviate.
- Prepared a safety plan, including critical safety activities and quality management (QM) activities. I monitored the project's execution to ensure compliance with the safety plan.
- Performed confirmation reviews of software requirements, architecture, and unit designs with appropriate safety measures to ensure the safety requirements.
- Conducted safety analyses using FMEA methodology for powertrain systems and made sure to derive safety measures.
- Supported many OEMs and tier 1 companies as a functional safety and quality engineer.
Technologies: Automotive SPICE, ISO 26262, Audits, Reviews, Presales
Supplier Software Quality Analyst | Engineering Process Group
2011 - 2014
Renault Nissan Technology & Business Centre India (RNTBCI)
- Coordinated and conducted organizational metrics and audits, collected and analyzed process improvements, and participated in the implementation of the rollout process as a member of the engineering process group.
- Handled supplier management and audits and managed supplier quality assurance tools.
- Developed ISO 26262, ISO 16949, APQP, and PPAP skills.
- Defined a level 3 quality management system within the organization.
Technologies: Automotive SPICE, Capability Maturity Model Integration (CMMI), ISO 26262, Vendors & Suppliers
Experience
AD Kit | Development and Process Enabling
Developed an AD kit that incorporates ADAS Level 2 features such as ACC, AEB, and LKAS and defined and implemented a process for an integrated management system based on ISO 26262, ASPICE, ISO 21448, and ISO 214343.
During this project, I worked closely with the customer's system engineering team to define item definition, functional analysis, and HARA and produce safety analysis documentation. This involved working on-site at the customer location to ensure effective communication and collaboration.
During this project, I worked closely with the customer's system engineering team to define item definition, functional analysis, and HARA and produce safety analysis documentation. This involved working on-site at the customer location to ensure effective communication and collaboration.
ASPICE Level 3 | Implementation and Enabling
Identified gaps in the customer's process, compiled a gap analysis report, and defined procedures, guidelines, checklists, and templates to address these gaps. This involved implementing the new process in pilot projects, conducting audits, and ensuring the process was integrated and standardized across the organization.
Education
2008 - 2010
Master's Degree in Business Administration (MBA)
Hibernia Institute - Brisbane, Australia
Certifications
DECEMBER 2020 - DECEMBER 2025
Quality Management Systems Auditor
BSI
APRIL 2019 - PRESENT
Functional Safety Engineer
TUV SUD
Skills
Tools
Automotive SPICE, Jira, IBM ALM, DOORS
Platforms
Windows
Languages
C++
Other
ISO 9001, Audits, Reviews, ISO 26262, Systems Engineering, Functional Safety, ISO 13485, Quality Management Systems (QMS), Business Cases, Marketing Mix, Requirement Traceability Matrices, Process Definition, FDA, CFR Title 21 Part 11, 21 CFR Part 820, MDR, ISO 14971, IEC 62304, Presales, Capability Maturity Model Integration (CMMI), Vendors & Suppliers
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