• 15 years of experience in R&D innovating and developing medical devices from initial concept to FDA approval, after that scaling and expansion of the product line• 5 years of start-up experience, managing software development of precision manufacturing processes to create custom orthodontic appliances (Aligners/Braces). Experience launching a product to market and scaling for mass production, MES implementation for production.• Lead System Engineering efforts with a team of cross-functional engineers to define high-level system architecture with inputs from the clients, product management, operations, and marketing teams.• 5+ years of experience in Verification & Validation of safety-critical medical device hardware, firmware, web software, and systems testing. Developed complete test plans optimizing test time with complete test coverage, risk management matrix.• Familiarity with FDA regulations for the medical device: MDR, 21 CFR 820, IEC 60601, IEC 62304, EN 45502. Key member for 4+ FDA product approvals.Computing Skills:• System Design & Simulation Tool: LabView, Xilinx ISE, Xilinx EDK, ModelSim SE, MATLAB, OrCad (Schematic layout), Allegro PCB design, 3-D Geometry software tools, PLC (Beckhoff), SQLite, SQL, 3D printing• Test Tools: Xray, IBM Rational RequisitePro. and DOORS, Atlassian Suite (JIRA, Confluence, bitbucket), SVN, Jama, Fisheye, Crucible, Bamboo• Programming Languages: C, C++, Python, PLC programming (Structured Text)