Hari Raman Email & Phone Number

Irvine, Ca, Us

Aliso Viejo, California, United States

• Created Terumo Neuro's first electro-mechanical center of expertise to develop next generation devices and technology. • Leading product development of electro-mechanical devices including mechanisms, solenoid drivers, motor controllers, sensors, firmware, software, mobile applications and machine learning. • Expertise in navigating stringent IEC/IS certification testing requirements with foresight in design combined with effective test strategies. • Expanding Terumo Neuro's offerings to disease states outside of Neuro-Endovascular by developing adjacent technologies.

Aliso Viejo, California, United States

• Developed Terumo Neuro’s post market device evaluation process including setting up state of the art Lab infrastructure and developing standard work.• Assembled a purpose built team of engineers and technicians and brought about marked change in thequality and timeliness of investigations. Achieved a 50% reduction in lead times.• Developed in-house chemical decontamination methods to expedite product decontamination andreduce the complaint closure lead time. Slashed decontamination lead times by at least 50%.• Managed the complaint handling team and systematically achieved a 50% reduction in complaint backlog. .• Instrumental in developing Terumo Neuro’s current generation complaint handling process to improvethroughput and efficiency.• Developed state of the art statistical procedures for complaint data trending and established actiontrigger limits for all MicroVention product families.• Liaised and collaborated with cross functional peers to initiate several formal corrective actions toimprove quality of device based on findings from product evaluation.

Orange County, California Area

•Led a team of Design Assurance Engineers and successfully transitioned into a proactive ‘Design in Quality’ and a ‘Design for Reliability’ approach.•Navigated NPD and Sustaining teams through FDA Design Control and Risk Management requirements for a wide variety of medical device projects. •Conducted quality systems, GMP and production readiness audits of suppliers and contract manufacturers located overseas. In two different instances, audit findings averted a recall situation.•Provided multidisciplinary engineering support and guidance for cross functional teams including mechanical, materials sciences, electrical and electronics engineering.•Developed and executed protocols for DOE, Clinical Trials, Gauge R&R and Process Validations, including setting statistically acceptable sample sizes.•Authored a wide array of technical reports across a broad range of topics including sterilization and sterile barriers, cleaning and disinfection of medical devices.•Compiled elaborate DMRs for complex electromechanical devices, working with product development teams and overseas contract manufacturers.•Coached and mentored junior staff across departments to help elevate the awareness and standard expected in a highly regulated industry.

Orange County, California Area

•Provided critical design for manufacturability (DFM) input for a variety of devices for endodontic and restorative dentistry. Areas of focus included multi-material enclosures (plastics and metal), mechanical components (e.g. micro-pumps and NiTi wires), LED engines, PCBAs and Supercapacitors. •Assessed global supplier capability for new electromechanical products for endodontic and restorative dentistry. Led line set-up and line improvement activities at two overseas suppliers for two different product lines.•Identified multiple cost reduction opportunities while preserving product performance and quality. In one case, a 40% price reduction for a critical component was achieved as a result of an effective supplier scouring campaign.•Oversaw testing, subsequent trouble shooting and successful passing of IEC 60601 requirements for complex electromechanical devices. •Managed suppliers in Asia Pacific region; working with them to develop product designs, manufacturing processes and quality control procedures. •Provided design assurance support to cross functional teams as an independent reviewer of design control elements, DFM and risk management (FMEAs and Hazards). •Identified gaps in design control and risk documentation and helped cross functional teams successfully adhere to the design control process.

Led and managing the Engineering Department. Responsible for overall tool and die design and manufacture. Lead Technical Specialist in Superplastic Forming and Tool Design for hot forming of Aluminum, Magnesium and Titanium alloys. Lead Materials Research and Development Engineer. Lead Engineer for Innovation in materials, manufacturing and technology.

Responsible for Tool and Die design and development for Superplastic forming. In house expert in numerical simulation and Finite Element Methods. Responsible for product and process development. Lead Materials and Manufacturing Engineer.

Responsible for evaluating designs of automotive powertrain components using advanced Finite Element Methods. Provided technical feedback and design recommendations to product design and product engineering.Participated in vehicle testing and field data processing and analysis. Developed a keen understanding of 4 wheel drive and All wheel drive systems in automobiles.

Developed a thorough understanding of high temperature superplastic forming of aluminum body panels. Developed expertise in HYPERMESH and ABAQUS and applied them to simulate the superplastic forming process. Improved simulation accuracy by developing an analytical model to determine an accurate material model.Conducted a grain size study of superplastic aluminum alloys under different heat treatments using optical microscopy and advanced imaging software. Presented technical results to Directors, Managers and Technical Specialists at Ford.Worked with a core team of experts on a limited production run to make prototype parts for Ford special vehicles.Participated in various cross departmental projects within Ford Research Labs.

Master Of Science (M.S.), Automotive Systems Engineering

Activities and Societies: Materials Engineering, Alloy Processing, Modeling Sheet Metal Deformation, Hot Forming, Finite Element Modeling

Bachelor Of Engineering (B.E.), Mechanical Engineering

Activities and Societies: Society For Automotive Engineers (SAE)

High School Diploma