Director of Engineering with a firm understanding of new product design and development under design controls, FDA regulations, cGMP practices, and QSR requirements. Passionate about building and growing an outstanding multidisciplinary engineering team to deliver products to market. “I believe the core of any company success starts with its team members.”• Leading and motivating cross-functional teams to define and develop complexity medical device from Concept Phase to Product Launch. Ensuring cross-functional teams operate effectively with positive team dynamics.• Managing all aspects of scope, resources, and timeline for the program. Creating and driving a go-to-market strategy while ensuring a successful commercial launch.• Hands-on product design/development with high-quality execution, technical rigor, and achievement of product design, engineering, feasibility/laboratory testing, and verification and validation of product development projects under regulated design controls.• Experience planning multiple work-streams, identifying risk and implementing action plans to optimize timelines and reduce execution risk• Experience establishing customer requirements from defined needs specifications and translating to product requirements• Experience with Rapid Prototyping, Finite Element Analysis (FEA), Part / Assembly Dimensional and Tolerance Analysis, Design for Manufacturability (DFM), Design For Assembly (DFA), Process / Failure Mode and Effects Analysis (PFMEA) and Design Input Requirements (DIR). • Work collaboratively with other members of the R&D team (regulatory, quality, marketing, and process development) to ensure a robust design that meets all performance, regulatory and quality requirements.• Experience in Supplier/Vendor Management including supplier qualification and selection, supplier performance reviews and cost reductions analysis.• Compliance FDA 21 CFR 820 and 13485 requirements.