Srikoundinya Sri P.
Principal Engineer 1 - Product Development at Illumina
- Role
- Principal Engineer 1 (Associate Director Grade) - Product Development at Illumina
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Srikoundinya Sri P.
Evolved naturally & organically as a Systems Engineering leader, w/ breadth & depth in a wide range of topics, & with a passion to drive teams from diverse backgrounds and launch great products that improve overall human health condition. Managed & mentored multiple Systems Engineers.16+ years in Product Development, spanning across Genomics (Next Gene Sequencing w/ SBS, DNA Library Prep), Digital Microfluidics, MEMS, & Microfab.Additional 8.5 years in academic research, in MEMS, Microfab, Artificial Lipid Bilayer Nanomembranes, & Digital Microfluidics.Areas of Experience: 1) Design Control Elements- DHF- Design & Development Plan- User Needs- Product Requirements (Design Inputs) for Performance, Attributes, Workflow, Interfaces, Safety, Compliance, Regulatory, Packaging, Labeling etc, with a structured approach to waterfall V model- Workflow Diagrams & Architecture Diagrams- Sub System Requirements across Instrument, Consumables, Reagents, Software, & Firmware- Design Outputs (Specs, Drawings)- Architecture, Technical Feasibility, and Design Reviews- Engineering verifications- System level Design Verification Plan, Protocols, Reports- Change Control Management- Design Validation of RUO- Design Traceability (all the way down to sub system requirements, Software Requirement Specifications, Firmware Requirements, Design and Manufacturing QC Specifications, Test Cases, and reports).2) Stakeholder Needs and Stakeholder (Business related) Requirements- Service & Support- Instrument Diagnostics- Manufacturing/Operations- Product Security- Extensibility to future- Dependencies on other internal projects etc.3) Problem Solving Skills- FMEAs- Critical Parameter Management (CPM)- Measurement System Analysis (MSA)- Kano Analysis- Pugh Matrix- Data Analysis- 8D- 5 Whys- Fish Bone etc.4) Risk Management- Hazards Analysis- Risk Assessments- FMEAs- Process improvements- Tools (Jama, Polarion etc.).5) IVD regulatory expertise- Served as a consultant for internal projects (FDA, EU, NMPA submissions). Guided Systems Engineers in supporting documentation for Regulatory submissions- RUO gap analysis for future IVD readiness- UCSD Certified in Regulatory Affairs for Medical Devices.6) Products so far, w/ significant contributions made- NeoPrep DNA Library Preparation System- Mondrian SP DNA Library Prep System- Mondrian SP+ DNA Library Prep System- NovaSeq X Plus- NextSeq NovaSeq MiniSeq7) Was a Certified Systems Engineering Professional (CSEP) for 3 years, issued by INCOSE.
Experience
Principal Engineer 1 (Associate Director Grade) - Product Development
Jul 2021 — Present · San Diego, CA, US
Systems Engineer in R&D, for RUO, IVD products.Products: NovaSeq X Series
Education
Koneru Lakshmaiah College of Engineering
B. Tech., Electrical and Electronics Engineering
1996 — 2000
University of Cincinnati
Ph.D., Electrical Engineering
2006 — 2011
University of Cincinnati
M.S., Electrical Engineering
2000 — 2003
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