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Roberto Hidalgo
Senior Director of Program Management
Professional Background
Roberto Hidalgo is a highly accomplished professional with significant experience in the medical device and biotechnology sectors, where he has successfully managed numerous product launches and strategic projects. With a stellar career that spans various leadership roles, Roberto has demonstrated his ability to deliver projects on time and within budget, achieving cumulative revenues exceeding $3 billion annually from successful product launches. His expertise lies not only in managing the lifecycle of medical devices but also in navigating the complexities of regulatory compliance, ensuring that all products meet the stringent standards set forth by the FDA and ISO.
Throughout his career, Roberto has held various influential positions that have honed his skills in program management and project execution. As the Senior Director of Program Management at Portal Instruments, he has played a pivotal role in guiding teams through the intricacies of product development while fostering a culture of innovation and accountability. Prior to this, he served as the Director of Program Management at Intersect ENT, Inc., where he led cross-functional teams to bring groundbreaking medical technologies to market.
Roberto’s previous experience includes roles such as Global Project Manager at Genentech, where he oversaw critical projects from conception through commercialization, ensuring alignment with organizational goals and market needs. His tenure at Boston Scientific, where he progressed through various roles from Sr Project Manager to Production Supervisor, allowed him to develop a comprehensive understanding of both operational and strategic management within the healthcare industry. Through these positions, Roberto has showcased his ability to utilize lean-agile methodologies to enhance productivity and mitigate risks, which are essential in today’s fast-paced product development environment.
Education and Achievements
Roberto Hidalgo's educational background is distinguished and emphasizes his leadership viewpoint and business acumen. He completed his MBA in Business Administration and Management, General at the prestigious Harvard Business School, which equipped him with strategic insights and management skills applicable to his professional endeavors. Prior to this, he earned a Licenciatura in Industrial Engineering from the Universidad de Costa Rica, which laid the foundation for his technical expertise and innovative approach to problem-solving in engineering and project management.
His academic and professional journey has not only prepared him to tackle the challenges of product management but has also allowed him to contribute to the innovation landscape within the healthcare sector. Roberto’s deep understanding of both the technical and business aspects of medical device development is a testament to his commitment to excellence and continuous improvement in his field.
Notable Achievements
- Successful Product Launches: Over his career, Roberto has successfully led more than ten product launches in the medical device and biotechnology fields, demonstrating his capability to transform ideas into commercially viable products.
- Revenue Generation: His leadership in strategic project management has directly contributed to generating annual revenues exceeding $3 billion, which highlights his impact on organizational growth and market presence.
- FDA and ISO Compliance: With an extensive understanding of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485, Roberto has ensured that the products he oversees adhere to high safety and quality standards, pivotal in building trust with consumers and regulatory bodies.
- Project Management Expertise: Roberto is well-versed in lean-agile project management methodologies, which enable efficient project execution and flexibility for adapting to changing business environments.
- Cross-Industry Experience: His diverse background spans both biotechnology development and pharmaceutical commercialization, making him a versatile expert capable of navigating various aspects of product development in healthcare.
As Roberto Hidalgo continues his impactful journey in the medical device and biotechnology fields, he is committed to leveraging his wealth of experience to foster innovation, create strategic pathways for product development, and ultimately enhance patient outcomes across the globe.
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