Akhil Menon
@akhilmenon
Process development engineer specializing in Class III medical devices, validation, and manufacturability improvements.
What I'm looking for
I am an accomplished process development engineer with deep experience in Class III medical device manufacturing, process validation (IQ/OQ/PQ), EU MDR remediation, and test method validation. I lead cross-functional projects to improve manufacturability, authored regulatory and technical documentation, and developed 30+ inspection methods, fixtures, and automated vision solutions using SolidWorks CAD to enhance accuracy and consistency.
I combine hands-on troubleshooting of electromechanical systems, DOE, SPC, PFMEA, and risk management with strong regulatory knowledge (21 CFR and EU MDR) to support compliant commercialization. I have driven remediation and re-commercialization efforts, executed IQ/OQ/PQ validations, and contributed to R&D scale-up and catalyst process optimization in academic research.
Experience
Work history, roles, and key accomplishments
Led remediation and process validation efforts for legacy Class III devices to meet EU MDR and FDA requirements, executing IQ/OQ/PQ and test method validations that strengthened traceability and manufacturability. Designed and validated 30+ inspection methods, fixtures, and automated vision systems to improve accuracy and reduce variability.
Supported R&D and scale-up of Class III thrombectomy catheters by optimizing cure times, designing assembly tooling and automated equipment, and conducting IQ/OQ/PQ and PFMEA to enable re-commercialization readiness. Authored validation protocols and work instructions to support regulatory submissions.
Research Assistant
Missouri University of Science and Technology
Jan 2019 - Dec 2021 (2 years 11 months)
Developed and characterized nanostructured catalysts and advanced process models, conducted DOE, Gage R&R, and validation protocols, and authored technical reports to support scalable manufacturing and publications. Applied ALD to synthesize catalysts and validated kinetics using DOE and Bayesian methods.
Business Analyst Intern
ADI Analytics
Feb 2018 - Oct 2018 (8 months)
Conducted market research and built quantitative models in R to evaluate project economics and market size for chemical and polymer clients, supporting business development and project roadmaps. Prepared client presentations and supported project managers on implementation plans.
Education
Degrees, certifications, and relevant coursework
Missouri University of Science and Technology
Master of Science, Chemical Engineering
Activities and societies: Authored research publications and presented findings at scientific conferences; conducted DOE, Gage R&R, and advanced analytics for catalyst development.
Completed a Master of Science in Chemical Engineering with research and thesis work on catalyst development, process optimization, and validation supporting scale-up and characterization.
Campbellsville University
Master of Science, Information Technology Management
Completed a Master of Science in Information Technology Management focused on project leadership, data systems, and cross-functional management to complement engineering expertise.
Jawaharlal Nehru Technological University
Bachelor of Science, Chemical Engineering
Completed a Bachelor of Science in Chemical Engineering with coursework and project experience in catalysis, process modeling, and manufacturing-focused design.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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