Pure Engineering...

• Non-Product Software   

  • Extensive experience on validation methodologies, processes and regulations, including FDA's Software Guidance, Part 11, EU Annex 11. Guidelines such as GAMP5 (Good Automated Manufacturing Practice), CSA (Computer System Assurance), SaS (Software as a Service), Equipment, ERP and IT software systems

    • Software System validation; Documention implementation (Validation Plan, Traceability Matrix, Product Specification, Functional Specification, Risk Assessment, System Design, IQ and OQ, PQ write up, execution, and Reports, Validation Summary Reports 

    • GxP and Part 11 Assessment, Software Classification/Level of Concern, Risk Assessment, Change Management activities using tools like TrakWise and Service Now. Familiar with ALM and JIRA

    • Expert in authoring, reviewing and mentoring Development Teams on write up of Validation documents, Standard Operating Procedures for reviews, writing software requirements, documenting code for maintainability, ensuring GDP (Good Documentation Practices)

    • Experience in enforcing adherence to regulatory requirements and standards during Project Planning, Project execution and Project delivery  

• Product Software, Medical Device Software, Embedded Software ​
  • Subject Matter Expert on implementing SDLCs for Waterfall, Agile/TIR45 under IEC62304,ISO14971
  • Proficient in compliance reviews of Development, Verification Activities,Deliverables required by IEC62304  
  • Validation of SaMD and embedded medical device software 
  • ScrumMaster. Former Software Developer
• Product Development-Hardware and Software
  • Design Controls-dFMEA, pFMEA, uFMEA, Risk Management, V&V, Design Transfer, DHF, DMR creation
• Non-Clinical Testing coordination with certified labs:Biocompatibility,Cytotoxicity,Sensitivity,Disinfection  
• Other Testing-Shelf Life, Packaging ​

​

• Summative Usability/Human Factors
  • Study Planning, Implementation and Execution. Usability Engineering File
• Regulatory
  • FDA PMA,510K,DeNovo. IDE (Investigational Device Exemption), Breakthrough Device   
  • MDR Technical File Preparation for Notified Body audit leading to CE mark and product certification
• QMS (Quality Management Systems) Implementation and Execution
  • Quality Manual Implementation-ISO13485, 21CFR Part820, 11, 210, 211, CAPA, Complaints, MDR, ISO14971