Alireza Ashani

About Alireza Ashani

Senior Medical Device Lead Engineer with an extensive background in medical device design, embedded system design, new product prototyping, and embedded device software. A dynamic team leader with well-developed verbal and written communication skills. Highly detail-oriented with a proven ability to meet deadlines and objectives. Broad experience working in a global environment, ability to collaborate closely and communicate effectively across diverse teams.Areas of Expertise: Medical Device Software, Combination Products, Project Management, Risk Management, Software Risk Control, Root Cause Analysis, FDA Regulations/Guidelines, Embedded Programming in C and Assembly on Cortex M3 ARM 7 (ARM7TDMI), and SiLabs 8051 targets, Linux Device Driver, Linux Userspace Applications, Linux Kernel and Customized RootFS Development on ARM 9 (ARM926EJ-S), Swift iOS, FPGAs, Embedded Security/Encryption, Secure Processors (Tamper responsive), DUKPT key management, Digital Signal Processing, Schematics Design, Part Selection, AMR/GMR sensors, EMI/EMC.Technical Tools: Rational Doors Next Gen, Minitab, Trackwise, Keil uVision, Eclipse, MATLAB, GitLab/GitHub/Stash Version Control, Orcad Capture, Agile PLM, SAP, Jira, Agilent Spectrum Analyzer, Oscilloscope, Labview.

Experience

1. Senior Medical Device Lead Engineer

   Amgen

   Jan 2017 — Present · Thousand Oaks, CA, US

   Lead software lifecycle management activities and design control within the electromechanical platform team for Amgen’s reusable autoinjector device, AutoTouch (AT) in accordance with Good Manufacturing Practices (GMPs). Act as SKU Team Lead (STL) for AT device. Effectively interact with Supply Chain and Product Quality to ensure materials procurement, and compliance to applicable standards. Proactively engage in Risk Management activities, providing effective software risk control measures. Provide support for formative/summative user validation studies. Lead compliance efforts to meet IEC standards 62304, 60601, Cybersecurity and MDSW guidance for Amgen’s electromechanical products. Manage Real Time Aging as an FDA commitment for the AT device. Lead root cause investigations, and drive product improvements for enhanced efficiency. Contribute actively to complaint code assessment, improving complaint code mapping/handling. Own/manage FAST (Failure Analysis Software Tool) for Return Unit Investigation (RUI) lab— Key Achievements:As AT device STL implemented software sub-system and cybersecurity improvements, resulting in 25% user complaint reductions.As the business owner of FAST tool, led investigation, root-cause analysis, and resolution of multiple functional issues in a short timeline, eliminating costly additional RMA steps. Authored CBE-30 and annual filings with FDA for AT device, and effectively responded to RTQs, resulting in successful approval of the AT device (2nd generation)— Major Device Projects:AT (AutoTouch): Amgen’s electromechanical reusable autoinjector platform device with BLE connectivity.Process Development: Software and Hardware Development Process for Medical Devices and Combination Products (SOPs, Templates, compliance checklists). FAST (Failure Analysis Software Tool): Returned unit investigation software tool for autoinjector devices.ARIA: Amgen’s next gen electromechanical reusable autoinjector platform device.

Education

• Wharton Online

  miniMBA, Business Foundations

• California State Polytechnic University-Pomona

  Master's degree, Electrical Engineering

  2000 — 2004

• UC Irvine

  Certificate, Embedded Systems Engineering

  2009

Skills

• Matlab
• Engineering Management
• Modelsim
• Vhdl
• Simulations
• Nfc
• Arm Cortex-M
• C++
• Ce Marking
• Allegro
• Oracle Agile Plm
• Emv
• Tqm
• Soc
• Mixed-Signal Ic Design
• Atmega
• 8051 Microcontroller
• Magnetics
• Fpga
• Asic
• Testing
• Electrical Engineering
• Atmel Avr
• Xilinx Ise
• Orcad Capture Cis
• Ecos
• Electronic Payment Processing
• Ul
• C
• Bluetooth
• Verilog
• Cygwin
• Sap
• Fcc
• Embedded Systems
• Analog
• Firmware
• Electronics
• Gnu Debugger
• Manufacturing