Experience

Agilent Technology

• India
• IT Services and IT Consulting
• 1 - 100 Employee

• Expert (Principal) Software Design Assurance Engineer / Software Quality / Design Control

  • Nov 2015 - Present

  California, United States Work on software design control/assurance/ cybersecurity of Pathology In-Vitro Diagnostic (IVD) instruments running on multiple software and embedded firmware. Collaborate with software R&D, marketing, regulatory, service, project and product management in the US and Denmark to ensure regulatory compliance to FDA and European IVD directive. Medical Device / IVD Standards and Regulatory Requirements: FDA 21CFR820 design controls, FDA Guidance documents including General Principles of… Show more Work on software design control/assurance/ cybersecurity of Pathology In-Vitro Diagnostic (IVD) instruments running on multiple software and embedded firmware. Collaborate with software R&D, marketing, regulatory, service, project and product management in the US and Denmark to ensure regulatory compliance to FDA and European IVD directive. Medical Device / IVD Standards and Regulatory Requirements: FDA 21CFR820 design controls, FDA Guidance documents including General Principles of SW Validation, OTS/SOUP, and Cyber-security. EU Council Medical Device Directive 93/42/EEC, EN ISO 14971 (Medical devices - Application of risk management to medical devices), AAMI TIR 32 (Medical Device Software Risk Management), EN/ IEC 62304 (Medical device software – Software life-cycle processes), EN ISO 13485: (Medical devices – Quality management systems – Requirements for regulatory purposes), In-Vitro Diagnostic Device Directive (IVD) - 98/79/EC 1988, AAMI TIR 45 (Agile SW Development for Medical Devices) Show less



Calhoun Vision, Inc.

• Software Firmware Test & Quality Assurance

  • Feb 2012 - Apr 2015

  Manage software test and quality assurance efforts for a first-in-the-world Ophthalmic instrument designed to enable surgeons to correct vision refractions after implanting intraocular lenses following Cataract surgery. This instrument runs on embedded firmware and Windows software application. Qualified Software/firmware builds for FDA trials and commercial & investigative applications in Europe and Mexico ● Actively participate in software initiatives. Conceive of software requirements and… Show more Manage software test and quality assurance efforts for a first-in-the-world Ophthalmic instrument designed to enable surgeons to correct vision refractions after implanting intraocular lenses following Cataract surgery. This instrument runs on embedded firmware and Windows software application. Qualified Software/firmware builds for FDA trials and commercial & investigative applications in Europe and Mexico ● Actively participate in software initiatives. Conceive of software requirements and features to delight our customers ● In a collaborative effort, performed gap analysis between European Medical Device Directive Software Life-cycle Processes (BS EN 62304:2006) and Calhoun Vision’s existing processes; identified corrective actions to close the gaps ● Participate in Risk management process to identify and mitigate potential product safety risks caused by software / firmware ● Acquire and deploy software tools to track software defects, manage software requirements, and to control software configurations. Show less



Medtronic Diabetes

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Sr. Software Engineer (Embedded Software Test Lead)

  • 2003 - 2011

  Northridge, CA ● Led a team of engineers to develop and execute Verification Test Specifications (VTS) for Glucose Sensors traceable to Software Requirement Specifications (SRS) and Software Design Description (SDD) ● Tests included White box, black box, integration, smoke, regression, load, exploratory, and performance testing ● Prepared project schedules based on available resources and overall product delivery milestones ● Assign tasks to team members, prepare reports on test progress ● Plan, distribute… Show more ● Led a team of engineers to develop and execute Verification Test Specifications (VTS) for Glucose Sensors traceable to Software Requirement Specifications (SRS) and Software Design Description (SDD) ● Tests included White box, black box, integration, smoke, regression, load, exploratory, and performance testing ● Prepared project schedules based on available resources and overall product delivery milestones ● Assign tasks to team members, prepare reports on test progress ● Plan, distribute, monitor, and provide metrics/reports for test efforts ● Represent the project test team to management ● Initiate frequent interactions with staff in software development, software quality assurance and other departments on software test status and software issues ● Maintain configuration management/control of documents in area of project responsibility ● Participate in project meetings in all phases of product development. Show less



Ameritec

• Insurance

• Sr. Software Development Engineer

  • 2001 - 2001

  Covina, CA Analyzed and resolved problems with software features of communication test products running on Digital Signal Processor (DSP) which resulted in securing high-dollar orders from Cisco and Nortel Networks • Worked with offshore product development teams for feature enhancements of network test equipment simulating telephony subscribers (analog circuits, T1, E1, ISDN) placing call into the network. • Developed automated test tools for network load generation products in networks composed of… Show more Analyzed and resolved problems with software features of communication test products running on Digital Signal Processor (DSP) which resulted in securing high-dollar orders from Cisco and Nortel Networks • Worked with offshore product development teams for feature enhancements of network test equipment simulating telephony subscribers (analog circuits, T1, E1, ISDN) placing call into the network. • Developed automated test tools for network load generation products in networks composed of signaling analyzers, switch simulators, and fax protocol analyzers. Show less



Nortel Networks

• Telecommunications
• 700 & Above Employee

• Software Developer - Project Prime

  • 1999 - 2001

  Worked on Digital Signal Processing (DSP) software features on Nortel’s Multi-service Access communication products (Passport 4400) ● In a project prime capacity, designed and implemented a DSP algorithm to detect and disconnect calls upon detection of supervision tones from PBX or Central Office lines ● Drew on the expertise of subject matter experts when needed ● Held meetings to present design, code reviews, and other activities associated with R&D ● Prepared schedules including tasks… Show more Worked on Digital Signal Processing (DSP) software features on Nortel’s Multi-service Access communication products (Passport 4400) ● In a project prime capacity, designed and implemented a DSP algorithm to detect and disconnect calls upon detection of supervision tones from PBX or Central Office lines ● Drew on the expertise of subject matter experts when needed ● Held meetings to present design, code reviews, and other activities associated with R&D ● Prepared schedules including tasks, milestones ● This feature included filtering, detection, and an elaborate cadence algorithm to prevent false detections during speech. Wrote the design, functional, and unit test specifications ● Features were developed and tested in C, then converted to Texas Instrument’s C54x DSP assembly ● Designed and Implemented telephony signaling protocols running on TI’s c54x DSP ● Ported a 500 Hz detector from C54x to C5x to enhance the ability of Fax Relay receiver to distinguish between V.21 and V.29 signals ● Wrote program in Matlab to evaluate the design; wrote code in C5x and C54x assembly to test the detector for bit exactness on C5x/C54x.

• R&D Software Test Manager

  • 1994 - 1999

  ● Managed engineers to test communication software features running on Texas Instrument TMS320C5x generation of Digital Signal Processors ● Prepared test project plans, schedules, budgets, performed employee reviews, assigned tasks, monitored and reported progress to director of R&D and other stake holders ● Provided technical leadership and coordinate software test cycle activities ● Developed test procedures, specifications, and plans related to product software test including white-box… Show more ● Managed engineers to test communication software features running on Texas Instrument TMS320C5x generation of Digital Signal Processors ● Prepared test project plans, schedules, budgets, performed employee reviews, assigned tasks, monitored and reported progress to director of R&D and other stake holders ● Provided technical leadership and coordinate software test cycle activities ● Developed test procedures, specifications, and plans related to product software test including white-box, functional, system integration, and systems tests ● Provided technical direction in design and implementation of automated tests for modem relays ● Participated in and presented at department level meetings, project status and problem solving results ● Participated in specifying, identifying and hiring the engineering and technical talent necessary to meet the project objectives. .