Time Delivery Software Engineer

TONY CHEN

617-***-**** – *******@*****.***

www.linkedin.com/in/tonychensw

DIRECTOR OF SOFTWARE ENGINEERING

MEDICAL DEVICES ~ SOFTWARE ENGINEERING ~ PROJECT MANAGEMENT Project/Team Leadership

Software Engineering

Processes

Application Testing

Technical Troubleshooting

Software Requirements

Quality Assurance

SHA/FMEA

Testing Methodologies

Test Plan Design

Cross-Team Collaboration

Cybersecurity

Highly motivated, talented, and analytical professional with 25 years of experience in building world class teams, managing the development of system firmware and software user interface design, and driving on time delivery of complex medical technology solutions. Maintains accountability for the overall software engineering lifecycle of software applications and executes projects against plans, budgets and delivery commitments. Comfortable with defining software verification and validation procedures in an FDA regulated environment. Skilled at resolving technical issues and conducting risk analysis activities. Accomplished communicator focused on strengthening relationships across functions to drive cohesive, strategic operations. Proven expertise in mentoring junior engineers and monitoring performance to promote a collaborative and accepting work culture.

BENCHMARKS & MILESTONES

• Autonomous robotic suturing in-vivo hernia repair: successfully demonstrated first ever in-vivo autonomous robotic hernia repair in live animal lab using combination of stereo vision and advanced path planning algorithm.

• Corneal Collagen Cross-Linking: Managed and developed software for a non-surgical eye correction device with UV technology using a photochemical process in corneal tissue. Released two cross-linking software from concept to production and stayed on schedule. Developed innovative authentication ideas.

• Surgical Robotics: Created an instrument control with 7 degrees of freedom and successfully integrated haptic feedback into the system.

• Rectilinear Biphasic Defibrillation: Developed software design, control methods and provided input on clinical research regarding the efficacy of the technology. Enhanced project schedule and product by providing a GUI simulation used in a focus group analysis. Released the product on schedule, eventually gaining wide acceptance as the preferred defibrillation technology to treat heart attacks. CAREER PROGRESSION

ACTIV SURGICAL • Boston, MA 2018-Present

Medical device startup developing technology that enables minimally invasive surgical robotic systems to perform surgery autonomously and advanced visualization to see real-time tissue perfusion using laser speckle contrast imaging. Technology stack: C/C++, C#/WPF/MVVM, RTOS, OpenCV, DirectX, IoT, SaaS DIRECTOR OF SOFTWARE ENGINEERING (2018-PRESENT)

Started the software/system program from the ground up. Architected, developed, hire, and drive the software development based on company strategy. Within 12 months, successfully demonstrated for the first time, performed in- vivo autonomous robotic hernia suturing in an animal lab.

• Developed an advanced laparoscopic vision system that enables surgeon to see blood flow and perfusion in real- time without ICG dye.

• Participated in FDA pre-sub meeting, to guide and confirm our regulatory strategy. TONY CHEN – PAGE 3

• Co-authored several provisional IP patents related to autonomous robotic suturing.

• Lead the requirement documentation from product, user, system hazard analysis, FMEA and all the software related documentation.

• Leading the strategy and development of our cloud solution (IoT, SaaS). Collaborate with internal scientists to create ML and AI models.

• Working with external partner to develop company cybersecurity program. AVEDRO • Waltham, MA 2008-2018

A leading medical device and pharmaceutical company with up to 120 employees and specializing in corneal cross-linking and refractive correction technology. Technology stack: C/C++, C#/WPF/MVVM, RTOS DIRECTOR OF SOFTWARE ENGINEERING (2012-2018)

Lead and mentor a team of five software engineers and conduct performance reviews to maintain a best-in-class engineering team and oversee development activities within a modified Agile environment. Manage each stage of the software engineering lifecycle for applications and execute project plans according to timelines, budget and delivery. Collaborate with engineering and marketing departments to devise strategies that optimize software design and deliver tactical technology solutions. Establish software development standards for FDA and CE compliance regulations.

• Oversee software development from concept to CE approval for cross-linking, non-invasive photo refractive device that consist of a camera system, optics and software controlling all peripherals and user interface.

• Successfully developed and released two cross-linking (CXL) devices using an existing platform and software architecture, resulting in a fast development time and increased sustainability for the company. SENIOR SOFTWARE ENGINEER (2008-2012)

Analyzed product requirements for selected components and developed software architectures while designing specifications for implementing requirements. Made suggestions regarding the direction of product development and collaborated with other departments. Contributed to automated testing for embedded device software and assisted with the transfer of tested software to manufacturing. Created software documentation framework that included SRS, SDD and V&V. Participated in all FMEA and risk analysis activities in line with continuous improvement initiatives.

• Conceptualized, researched, and developed an eye-sensing algorithm in software that minimized the complexity of electrical and mechanical components and resulted in cost savings.

• Designed RF energy detection within one millisecond of accuracy that allowed precise control of measurements. CAREER PROGRESSION (CONT.)

CAMBRDIGE HEART • Bedford, MA 2004-2008

A company that engaged in research, development and commercialization of durable goods, medical and hospital equipment for non- invasive diagnosis of cardiac disease SENIOR SOFTWARE ENGINEER

Drove software requirements and architecture with a focus on functionality and a secure software design. Conducted software test definition and testing with other engineers. Led a small software team and assisted in achieving project outcomes that included adhering to a product timeline and budget with limited resources. Created a new and intuitive user interface with a focus on responsiveness, consistency and efficiency.

• Developed the next generation of T-Wave Alternans software application for HearTwave II system based on existing products CH2000 and HearTwave I. Tracked this process from concept to FDA approval to monitor time, cost, scope, quality, risk and approval.

ENDOVIA MEDICAL • Norwood, MA 2001-2003

A medical device company with up to 50 employees and specializing in physician guided robotic systems for minimally invasive urology, gynecology and bariatric surgeries in the United States and Europe SENIOR SOFTWARE ENGINEER

Collaborated with research and design teams to develop and implement event-driven embedded C/C++ applications and distribution system. Investigated anomalies and performed risk analysis, testing and fixing bugs.

• Oversaw the development of software for a laparoscopic surgical product from concept to execution. TONY CHEN – PAGE 3

• Designed and created a GUI on NEC 6.5” LCD that provided ease of use and access to all functionalities within three button presses. Devised a high-speed communication protocol between the console and four or more motor controller in the device.

Previous positions include Software Engineer II at Zoll Medical & Software Design Engineer I at Simplex. TECHNOLOGY PROFICIENCIES

Applications/Languages: WPF, C#, MVVM, C/C++, JAVA, OpenCV, HTML, JS Operating Systems /

Software/Hardware:

Azure, Microsoft.NET, Embedded System, Software Development Lifecycle & Management, Software Design & Architecture, IEC-62304, ISO-14971, FDA Regulated Environments, RF, RFID, Vision System, Motion Control, QNX, RTOS, uC/OS-III EDUCATION AND CERTIFICATIONS

UNIVERSITY OF MASSACHUSETTS, Amherst, MA

BACHELOR OF SCIENCE, COMPUTER SYSTEM ENGINEERING

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