Edwin Bland

Sr. Manager, Systems and Risk Management, ISO-14971 & IEC-62304 SME, Risk owner for Class II,III medical devices, Systems Engineer, SW Engineer

Role
Sr Manager, Systems Engineering and Risk Management Coe (Center of Excellence) at Baxter International Inc.
Location
Mansfield, TX, US
LinkedIn followers
500 followers

About Edwin Bland

25 years Embedded Systems design experience5 years Physical Therapy work experience (Inpatient, Outpatient, SNF, Wound Care)Goal: Systems Engineering Leadership, Systems Device Design roleSkills Summary:Systems Engineering: Hazard Analysis, Operational Analysis, Needs Elicitation, Needs to Requirements translation, Functional Analysis, Risk Assessment, System Architecture tradeoff analysis, Lifecycle analysis, Requirements allocation and decomposition, Test Planning and coverage assessment, INCOSE aligned 14971 Risk Management FrameworkTools: Matlab, Polarion, DOORS, Trackwise, Agile frameworks, SAPRisk Process: ISO 14971 SME, IEC-62304 SMEPersonal: Excellent interpersonal, communication and leadership skills.Software: C,C++/Assembly (Most of them), Java Scripting(JScript, Perl, Bash, Python), Database: PostgreSQL, MySQLSW elements: Posix Threads, TCP/IP, I2C, SPI, UARTS, TIMERS, 1-WireTM, CAN, USB(MSC,CDC)Linux BSP & driver development:(PPC5200, PPC823, MIPS32-Tx3927, ARM9)BootROM: U-boot: TI ARM9 (DM368) & UBL, Blackberry BootromuClinux BSP usage & driver development: MCF5206, MCF5249, MCF5232, Blackfin 561OS: uC-OS-ii, FreeRTOS, Cooperative Scheduler/Dispatcher, Linux, QNX, MQXVersion Control: Subversion/SVN, PVCS, SourceSafe, Perforce, GitHardware: Highly skilled with new board startup & debugging with reference to schematic & boardlayout files. Timing/Logic analysis via Logic Analyzer/oscilloscope.EDUCATION: MPT (Master of Physical Therapy) Loma Linda University, Loma Linda, CA Accumulative GPA = 3.6/4.0BSE (BS Electrical Engineering) Walla Walla University, College Place, WA Accumulative GPA = 3.5/4.0Specialties: Product Risk Management, Systems Engineering, Embedded Software Design, Physical Therapy

Experience

  1. Sr Manager, Systems Engineering and Risk Management Coe (Center of Excellence)

    Baxter International Inc.

    Feb 2024 — Present · Skaneateles Falls, NY, US

    Training owner: Created INCOSE aligned Systems Engineering & Risk Management training material: Operational workflows, Needs elicitation, Needs to Requirements translation, Lifecycle Analysis, Risk Management, System Architecture tradeoffs, Requirements allocation, Test Planning & coverage assessment.QMS updates for risk processes.Review/Approve Risk Management project deliverables.Product Risk Reviews (Periodic, Event, NPD).Polarion PLM updates for new risk process.Risk impact owner: NCRs, CAPAs, Field ActionsSkills: Systems Engineering · Risk Management · Project Plans · Product Design · Requirements Management · Change Control · NCRs · Field Actions · CAPAs

Education

  • Walla Walla University

    Bachelor's Degree, Electrical Engineering

  • Loma Linda University

    MPT, Physical Therapy

Skills

  • Systems Engineering
  • Systems Design
  • Physical Therapy
  • Firmware
  • Labview
  • Data Acquisition
  • Automation
  • Integration
  • Real-Time Operating Systems (Rtos)
  • R&D
  • Diagnostics
  • Control Systems Design
  • System Design
  • Rtos
  • Electronics
  • Software Development
  • Engineering
  • Software Engineering
  • Embedded Software
  • C
  • Programming
  • Debugging
  • Design Control
  • System Architecture
  • Medical Devices
  • Arm
  • Simulations
  • Microcontrollers
  • Testing
  • Electrical Engineering
  • Product Development
  • Device Drivers
  • Embedded Systems
  • Hardware Diagnostics
  • Digital Signal Processors
  • Linux
  • Software Design
  • C++
  • Iec 62304
  • I2c

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Edwin Bland — Sr Manager, Systems Engineering and Risk Management Coe (Center of Excellence) at Baxter International Inc. in Mansfield, TX, US | Unifers