Priya Kulkarni Email & Phone Number

Concord, California, United States

• Direct cross-functional global team with indirect oversight of 30+ team members, responsible for portfolio ownership of flagship product, INTERCEPT® Blood System, for a biotechnology company• Lead multi-million-dollar portfolio program, leading strategic planning and execution of the product roadmap, ensuring alignment with business objectives and market demands• Guide cross-functional teams on product lifecycle from R&D to commercialization, for feasibility/concept, system design, design controls, product usability, verification/validation, clinical evaluation, compliance testing, regulatory submissions for CE mark and PMA, procurement/manufacturing, and commercialization• Oversee tracking and reporting key performance indicators (KPIs) to executive leadership, providing insights on portfolio performance and potential areas for improvement to senior level management and C-Suite• Played a pivotal role in driving organizational efficiency and effectiveness by introducing robust program management processes and practices, including introducing prompt engineering in program management • Provide coaching and mentoring

Concord, California, United States

• Managed strategic planning and delivery of hemodialysis product roadmap with multimillion-dollar budget and guided teams from initial R&D to product launch towards ~$1.5B+ in annual revenues• Mentored and led global team of 8 engineering project managers across multiple SW and HW projects• Spearheaded cross-functional, multi-site, global team of 70+ people, managing $50M+ portfolio program across complex stakeholder groups within a highly matrixed organization of 22K employees • Guided operations and strategic decisions, including next generation of project plans, development of resourcing strategies, and development of strategic partnerships with external partners, acquisition and allocation of resources, and risk management• Subject matter expert to Senior Staff for employee engagement, business growth, and roadmap management• Incorporated voice of customers in development plans by coordinating with marketing, SW/HW engineering, clinical, regulatory, quality, operations, and manufacturing departments• Accelerated operational performance 30%, initiating R&D division transition from Waterfall to Agile/Scrum• Optimized resource utilization by 20% by establishing effective results driven value streams• Implemented KPIs to present project data to C level executives and guarantee transparency and predictability in meeting project target with aggressive cost and performance targets• Key member of team responsible for achieving US FDA product clearance, following new product release, leading entire program from connect to commercialization• Led recruitment and hiring process for R&D and program management group, growing the program management team from 4 to 12 in the span of 2 years to support growing portfolio initiatives

Dublin, Ca

• Led 20+ cross functional team members to develop and commercialize next-generation high tech imaging devices and mentored 3 junior program managers on agile transformation and global collaboration• Managed all facets of the product development lifecycle, including feasibility/concept, system design, design controls, product usability, verification/validation, clinical evaluation, compliance testing, regulatory submissions for CE mark and 510(k), procurement/manufacturing, and commercialization• Successfully delivered programs within CIRRUS- OCT and Clarus 500 retinal imaging diagnostics portfolio, generating over $100M in annual revenues globally• Maintained market leadership with company’s flagship product, ensuring the ongoing market segment domination as the #1 best-selling product• Delivered project within approved budget and maintained target COGS of the device by optimizing resources• Reduced time to market by introducing best practices in project planning, requirements definition, risk management, vendor partnership, authentic teamwork, project execution and performance coaching

Dublin, California, United States

- I trained and directed a global cross-functional team centralized on creating instrument and review software to revamp the patient diagnosis process for Ophthalmologists. -I maintained market leadership with the company's flagship product continuing to dominate the market segment as the #1 best-selling product.

Dublin, California, United States

Dublin, California, United States

Dublin, California, United States

Pune, Maharashtra, India

Bachelor Of Science - Bs, Electrical Engineering

Post-Graduate Diploma In Advanced Computing

Executive Training, Women In Leadership