Director, Medical Devices (Jan 2018 – Apr 2018 )

• Responsible for strategic planning of medical device business unit, including marketing strategy, membership organization selection, development of key business alliances, and hiring plan.

• Interfaced with potential clients, including development of project proposals and NIH grant applications.

• Acted as subject matter expert for Fortune 500 company entering the combination medical device landscape. Responsibilities included drafting and reviewing SOPs pertaining to device planning, capturing of design inputs, risk management, traceability management, and design verification while ensuring compliance to appropriate ISO standards (e.g. ISO 13485:2016, 14971:2007, 62366-1:2015).

• Created verification test plans and protocols for combination medical devices including sampling plan and statistical justification.

Project Manager, Medical Devices (Sep 2015 – Dec 2017 )

• Oversaw teams of up to seven engineers developing products within diagnostics, orthopedics, gastroenterology, wound care, minimally invasive surgery, and drug delivery.

• Identified external knowledge experts and development partners to complement internal resources.

• Provided technical guidance for mechanical design, electrical design, and software architecture.

• Acted as knowledge expert for medical device development requirements including FDA and ISO regulations, external testing requirements, and good manufacturing practices.

• Performed root cause analysis for wearable insulin injector to address high rate of failure due to non-firing of the device.

• Evaluated long-duration drug delivery mechanisms for potential IP generation.

• Developed novel insertion tool for total hip replacement, resulting in four patent applications.

• Redesigned existing small joint fixation screw to increase reliability and reduce complexity.

• Established project teams and managed project timelines and budgets.

• Created and maintained device history and risk management files.

Systems Engineering Manager (Jan 2011 – May 2013)

• Managed day to day operations of systems engineering group, overseeing three engineers.

• Maintained design control policy to meet FDA 21 CFR requirements.

• Project manager and technical lead for flagship “IntelliGuide” CO2 surgical laser system, resulting in first year revenues of over $5 million. Responsibilities included ownership of the complete product lifecycle, from gathering customer requirements to design, verification and validation testing, risk management, creation and maintenance of the device history file, establishing manufacturing processes, and market launch.

• Evaluated new technologies for potential inclusion in product pipeline.

• Co-developed business case and designed initial product offering for entry into laparoscopic gynaecology surgical market, which now represents company’s core business strategy.

Design Engineer (Sep 2004 – Dec 2010)

• Designed over a dozen fiber optic surgical instrument tools for otolaryngology, head and neck, neuro, and spine surgery; used successfully in over 50k surgeries.

• Developed custom instrument program allowing rapid fabrication of one-off surgical instruments for clinical use, resulting in product turnaround times of under 4 weeks.

• Researched and commercialized disposable gas filter unit, allowing company to expand into closed cavity surgical procedures. Responsibilities included product design, packaging and labeling, ETO sterilization validation, and vendor selection.

• Designed and fabricated both mechanical and electrical inspection tools, including PCB design.

• Applied six sigma principles to address quality issues within fiber optic manufacturing process.

• Assisted IT with developing in-house intranet, including company wiki and .NET/SQL coding.

• MBA, GPA 3.87 / 4.0, May 2015

• MS, Mechanical Engineering, GPA 3.83 / 4.0, May 2015

• BS, Electrical Engineering, May 2004