Reza (Ray) Imani
Process Development Manager and Principal Mechanical Engineer with experience designing implantable medical devices from concept to full-scale production. Known for working closely with product development through design verification, manufacturing process development, process characterization, validation, and process remediation as respond to FDA warning letter. Enthusiastic manager of engineering teams, taking action to identify root cause and implement optimal solutions to ensure compliance with strict quality standards and FDA regulations. Technical & Specialized Skills include:
People Management Project Management Team Leadership Process Development & Validation
FDA Remediation Stack-Up Tolerance Analysis FE Analysis PTC CREO Design, Modeling, Drafting (GD&T)
Abbott, previously St. Jude Medical, Sylmar, CA
Manager, Process Development and Tooling 2010 – 2017
Managed cross-functional team of 7 engineers and interns through new process development and sustaining engineering / tooling production to support product requirements for manufacturing.
•Led conceptualization and deployment of Abbot’s first laser etching process, reducing assembly costs and lead times and improving manufacturing yield.
•Ensured FDA compliance by working with product development, quality, and program management to validate various processes, troubleshoot and resolve complex issues, and respond to FDA warning letters.
•Improved manufacturing productivity by managing multiple projects to automate and validate various processes, including:
oCreated semi-automated Laser process, replacing manual hydro-honing and grit blasting process.
oImplemented a laser process to remove parylene coating from device battery and header electrode.
oCreated Micro epoxy dispensing process to attach a pre-molded header to a Ti case.
oDesigned a Laser 2D barcode device for better traceability of devices in MFG.
oDeveloped method for adding RF ID tags to MFG tools and fixtures to keep track of tools in the production area.
oValidated plasma cleaning process to clean and remove wax from pre-molded header assembly parts.
oDeveloped test method for contact angle measurements used in validating cleaning process.
•Simplified manufacturing process by using peeling and sticking moisture-getters versus an alternate process dispensing and curing.
•Streamlined pre-molded and feedthrough into a 2-step injection process.
•Built collaborative team environment by providing training and mentorship to junior staff, promoting open communication, and working closely to identify root cause and resolve simple / complex issues.
Principal Mechanical Engineer 1999 - 2010
Developed mechanical design requirements for Implantable Medical Devices Reviewed and approved stack up tolerance and FE analysis, PTC Creo Design, Modeling, and Drafting (GD&T) of device internal / external components (feedthrough, hybrid, RF electronics, RF antenna, device housing, device header), and assembly drawings.
•Worked directly with suppliers from design concept thru procurement to procure cost-effective components
•Established device build documentation to build devices for validations and Biocompatibility testing.
•Designed contact springs as an alternate electromechanical connection to wire bonding.
•Developed and characterize voice coil to be used as patient notifier for pacemaker, ensuring compliance with regulatory and quality standards.
Boeing, previously SpectroLab, Sylmar, CA
Mechanical Design Engineer
Master of Science, Mechanical Engineering (MSME), University of California, Santa Barbara, CA
Bachelor of Science, Mechanical Engineering (BSME), University of Portland, Portland, OR
•Hermetically Sealed Feedthrough Connector Using Shape Memory Alloy, US 6498952 B2
•Inverted E Antenna with Capacitance Loading for use with Implantable Medical Device, US 9048541 B2
•Feedthrough Filter Assembly with Header Side Bunched Conductor Array and Can Side Linear Conductor Array, US 8649869 B2
•Method of Manufacturing an Implantable Pulse Generator, US 8700159 B2
•Internally Grounded Filtering Feedthrough, US 7046499
•Implantable Pulse Generator Feedthroughs and Methods of Manufacture, US 8155743 B2
•Feedthrough Filter Assembly, US 7391601 B1
•Implantable Pulse Generator Feedthroughs and Methods of Manufacture, US 8560071 b2
•Injection molding pre-molded header and feedthrough and welding it to Ti device case, patent pending
"MRI-induced Vibrations in Active Implantable Medical Devices: effect on Device," Proceedings of the International Society for Magnetic Resonance in Medicine, 2012. http://cds.ismrm.org/protected/12MProceedings/files/2762.pdf