Risk Management Quality Engineer

SHIVA RATAKONDA

Email Id: **************@*****.***

Mobile: 815-***-****

Professional Summary:

Over Nine years of experience as a Sr Software Design Quality Engineer with expertise in Product Development, DHF remediation, EU MDR, Design Controls, NCR, CAPA, and Risk Management.

Proficient in SDLC processes, requirement management, testing, risk assessment, configuration management, problem resolution, cybersecurity, clinical, usability, post-market surveillance, etc.

Skilled in Medical Device SDLC, IEC 62304, Medical Devices, Digital Health, Cloud and Mobile Applications.

Working knowledge of Software as a Medical Device (SaMD), SIMD, and related regulatory strategies.

Working knowledge of CAPA software and Product Lifecycle Management Software (Polarion, Vault, DOORS).

Extensive experience working in SAMD, Cardiovascular, Electro-Mechanical Products, and Orthopedic Products as a Quality Engineer with an emphasis on Design Controls and Risk Management.

Experience in DHF Creation, FDA, 820 CFR Part11 Compliance, Management, and Review.

Proficient in US FDA and International regulations as well as applicable standards, including ISO 13485, FDA QSR, MDD/MDR, ISO 14971, IEC 62304, IEC 62366, 21 CFR 820, 21 CFR Part 11, TIR 45, etc.

Oversee risk management processes for software as a medical device (SaMD), ensuring alignment with ISO 14971, IEC 62304, and cybersecurity best practices.

Experience authoring, reviewing, and approving design control risk management documents such as hazard analyses and design and process FMEAs and reports.

Experience with Design Control procedures for proper development and control of design plans, design documents and specifications, protocols, results, etc.

Experience with quality system design related to design control or risk management processes (ISO 14971).

Experience in DFMEA, PFMEA, and Risk Analysis documents for medical devices.

Experience using continuous improvement tools like FMEA, Root Cause Analysis, and SPC analysis.

Knowledge of ISO, ASTM Standards, and GD&T Techniques.

Strong knowledge of Microsoft Office Suite and statistical software packages (Minitab).

GE Health Care (Remote)

Sr Software Design Quality Engineer August 2023 - Present

Role & Responsibilities:

Developed the software quality management system in compliance with ISO 14971, ISO 13485, ISO 62366, IEC 62304, 21 CFR Part 820, and 21 CFR Part 11.

Lead, execute, and support the on-time completion of Quality Engineering deliverables from product concept through commercialization, including risk management activities (RMF, FMEA, Cybersecurity Risk Assessment).

Lead in creating and reviewing risk management files, including the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.

Participate in design reviews, code reviews, defect tracking and reviews, and software validation activities.

Ensure the completeness and full coverage of software verification and validation (V&V) protocols, including unit testing, integration testing, and system testing.

Assess product cybersecurity risks and maintain safety risk documentation throughout the product lifecycle. This includes reviewing vulnerability assessments, threat modeling, and risk analysis.

Derived Risk Management Team Meetings revised the strategies for approaching Risk Management activities and mitigated the risks by identifying and implementing accurate risk control documents.

Perform SOUP assessments for the products and maintain cybersecurity SBOMs throughout the product lifecycle.

Provided Subject Matter Expert (SME) consulting on global medical device regulations and standards. This included product marketing conformity requirements such as design history and technical files.

Traceability between product requirements, development tickets, and test tickets in JIRA. Supported in assessing the risk impact of design changes post-design-freeze and production.

Reviewed and validated SDLC Documents, which included GxP Requirements and Test Protocols. The test cases included validation of electronic records, electronic signatures, CAPA records, and Audit Trail.

Reviewed verification and validation (V&V) dry runs to ensure the design meets the specified requirements.

Facilitate the completion of various design control documents (project plans, design inputs/outputs risk, etc.) and maintain design history files to ensure adherence to quality procedures.

Design controls and supports validation of custom, configured, and non-configured software via review and approval of URS, FDS, FMEAs, protocols, Software Architecture, Design Documents, and protocols.

Review quality system nonconformances as a subject matter expert to ensure compliance with procedures and to assess whether escalation to CAPA is warranted.

Drive CAPA activities from issue identification to closure; effectively project manage all CAPA activities; ensure the quality of CAPA record content; and represent CAPAs during audits and CAPA Review Board meetings.

Worked with a team to create templates for design documents. Perform significance and impact assessments for Complaints Management.

Execute the verification and validation of product design, including requirements analysis and traceability assessment. Support completion of traceability of requirements through verification and validation reports.

Lead cross-functional teams over the entire life cycle and deal with regulatory and marketing to ensure project milestones and timelines are on schedule.

Created summaries of manufacturing processes, systems verification and validation protocols and reports, risk assessments, a list of applicable standards, general safety and performance requirements, and a declaration of conformity about EU MDR.

Intuitive Surgical, Sunnyvale, CA

Sr Software Design Quality Engineer October 2020 – August 2023

Role & Responsibilities:

Develop, implement, and maintain software quality processes in compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.

Provide software design quality assurance and ensured external and internal quality system requirements were adhered to throughout product and process lifecycles.

Performed risk assessments and validation assessments for product and process software changes. Identified gaps, suggested solutions, and led enhancement to software validation procedures, processes, and practices.

Ensure the completeness and full coverage of software verification and validation (V&V) protocols, including unit testing, integration testing, and system testing.

Created and maintained documentation in DHFs, including I/O Matrices, Product Specifications, Design Verification & Validation Reports, and External Standards Memos using Polarion.

Worked as a Risk management team lead in developing the Use and Design FMEAs for medical devices to be compliant with ISO 14971:2019

Led the da Vinci system software releases for the Business Unit; launched multiple central GEN4 system (X/Xi/SP) and simulator software releases.

Execute the verification and validation of product design, including requirements analysis and traceability assessment. Support completion of traceability of requirements through verification and validation reports.

Lead cross-functional meetings to resolve bugs and improve the documentation process. Review all design and risk documentation for quarterly software releases to ensure compliance with IEC 62304 throughout SDLC.

Participates in the Software Review Board (SRB) to evaluate and disposition software issues and Unresolved Anomalies.

Reviewed and approved Quality documentation/records for the software life cycle process to ensure that the verification and validation process meets company and FDA standards.

AbbVie (Remote)

Software Design Quality Engineer January 2019 – October 2020

Role & Responsibilities:

Perform Quality Engineering activities throughout the design and development to ensure compliance with Design Control procedures and regulatory requirements (specifically, FDA 21 CFR 820 and ISO 13485).

Lead quality activities, including guiding Design Controls, Risk Management, Change Control, and decisions on product development activities to ensure continued compliance with applicable regulations.

Lead quality support activities for SaMD, SIMD launches, and Digital Health tool (GxP application).

Coordinate QMS and technical documentation teams to assess gaps in processes, procedures, and information within specific requested technical documents for review against FDA and MDR standards.

Developed internal product firmware and software development life cycle procedures to comply with the IEC 62304.

Provided valuable input on system and component requirements, specifications, detailed designs, risk management activities, and verification and validation test strategies.

Provide guidance, mentoring, and coaching to CAPA owners throughout the CAPA process (initiation, investigation, action, and effectiveness phases), including utilizing various root cause analysis tools.

Responsible for the risk management process, which involves assessing, mitigating, and reviewing the risks involved at various design (DFMEA) stages of a medical device.

Performed design transfer activities to ensure product design requirements and outputs were adequately translated into production specifications.

Execute the verification and validation of product design, including requirements analysis and traceability assessment. Support completion of traceability of requirements through verification and validation reports.

Responsible for review and approval of NC and CAPAs, with attention to detail and review for completeness, accuracy, effectiveness, and timeliness.

Established several strategies to perform Design Validation activities by complying with IEC 62366.

Lead and participate in risk management activities, develop risk management plans and reports, and perform hazard analysis and FMEAs to evaluate and ensure product safety and functionality.

Drafted supporting documentation for the project’s DHF, including design verification/validation protocols, tolerance stack analyses, CTQ, detailed drawings, rationales, and design change orders.

Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation and resolution activities.

Performed Gap Analysis, documented and defined the gaps, and wrote a Remediation Plan to bring the system in compliance with 21 CFR Part 11 Regulation.

DePuy Synthes (J&J), West Chester, PA

Software Design Quality Engineer May 2017 – December 2018

Role & Responsibilities:

Supporting the quality processes conforming with DePuy Synthes, which complies with regulations and external standards, including risk management and change control per EU MDR, ISO 13485, and ISO 14971.

Supported design control and risk management processes, including developing quality & risk management plans & reports; conducted hazard analysis, DFMEA, and authored verification and validation protocols and reports.

Reviewed and approved Quality documentation/records for the software life cycle process to ensure that the verification and validation process meets company and FDA standards.

Lead a team to prepare and update the Summary of Technical Documentation (STED) files for submission to European Notified Bodies for timely CE marking of modified products, with appropriate input from supporting functions (Labeling, R&D, Quality, Manufacturing, Operation, Packing, Regulatory).

Worked on Risk Management Plan, Use Specifications, Hazard Analysis, User Failure Mode Effect Analysis, DFMEA, PFMEA, Risk Management Report, and Risk-Benefit Analysis per ISO 14971.

Provide input on CAPA escalation, root causes identified, proposed corrective actions, and effectiveness strategy as a member of the CAPA Board.

Lead the development of quality plans, CAPAs, supplier qualifications, and support verifications and validations.

Conducting design reviews to ensure all design changes are identified, documented, validated, verified, reviewed, and approved before the implementation.

Participate in Product Review Boards, identify non-conformance trends, and develop technical investigation plans. Investigate and analyze customer/internal complaints.

Experience with Design Verifications and Validation activities and creating linkage between ISO code specifications for User Needs.

Support the Internal CAPA Program as required, performing CAPA investigations, identifying root causes, implementing corrective/preventive action plans, and verifying effectiveness.

Drive a quality mindset and ensure work is performed according to appropriate quality requirements and compliance standards (e.g., risk management, design controls, ISO standards, etc.).

Support Review and Approval of EU MDR Change Projects and Quality Functional Impact Assessments. Perform a gap analysis of the group’s portfolio of products and technical files regarding the new regulations.

Experience working with PLM Systems (Windchill, Adaptive, Agile) for document control processes to review drawings and approve Change Requests (CRs) related to changes required to support compliance with EU MDR.

Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product Information.

Collaborate with suppliers to obtain details for manufacturing process information, production risk management, and direct marking and update the product’s technical file in compliance with EU MDR requirements.

Support the Review and Approval of Supplier Process Validation Protocols and Reports and update supplier-related Inspection Criteria as applicable.

Zimmer Biomet, Warsaw, IN

Design Quality Engineer February 2016 – April 2017

Role & Responsibilities:

Experience creating and reviewing design history files (DHF) supporting the Food and Drug Administration (FDA), including Design Inputs and Outputs, Design Reviews, Design Transfers, and Design Changes.

Developed Design Control (CFR 820.30) and Risk Management files by ISO 13485, 14971, and corporate procedure.

Worked with cross-functional teams to develop and document all phases of DHF creation.

Worked with post-market engineering and physicians for feedback and leveraged complaint analysis to revise existing implant and instrument use risk analyses.

Working with the team to ensure the process of customer complaints, engineering changes, and non-conforming products for the implants and instruments.

Performed Gap Analysis, documented and defined the gaps, and wrote a Remediation Plan to bring the system in compliance with 21 CFR Part 11 Regulation.

Developed Failure Mode Effects Analysis (FMEA), Risk Analysis, and Master Validation Plan (MVP).

Participated in CAPA meetings and activities and helped identify the root causes of the manufacturing problems.

Performed GAP Analysis of existing Risk Management Plans and suggested Remediation activities.

Conducting weekly design reviews with the manufacturing and the cross-functional teams, solving gaps in the remediated documents relevant to specific Design History Files (DHF).

Created a Risk Management Plan and Risk Management Report compliant with QSR 820 and ISO 14971.

Participated in devising ways to effectively implement the principles of Lean and support a culture of continuous improvement.

Education

Northern Illinois University, Dekalb, Illinois, USA – M.S., Mechanical Engineering

Osmania University, Hyderabad, India – B.S., Mechanical Engineering

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