Director Of Product Development
CurrentA company provides innovative design and development services for optical-based IVD devices and microfluidic-based POC assay technologies , along with support for regulatory compliance and clinical trial management.• Create roadmap and define product specification to target market needs. • Improve strategic planning and communication through creating clear, practical plans and timelines that enable teams to make well informed decisions. Implement a robust project management framework throughout the organization. • Evaluate project needs and prioritize tasks. Oversee entire program lifecycle, from planning to execution, ensuring projects are delivered on time, within scope, budget and to quality standards. • Lead product development, collaborate with cross-functional team of 10-12 members, including engineering, design, manufacturing and regulatory affairs, to integrate and develop the product. Manage interdependencies, align focus, and maintain project coherence.• Identify, assess, and manage project risks. Proactively address issues to ensure timely resolution and on time project delivery.• Manage regulatory compliance, ensuring all products comply with relevant regulatory standards and requirements throughout the lifecycle, such as ISO13485. Work closely with regulatory teams to navigate complex compliance landscapes.• Drive continuous improvement initiatives to improve project practices, contribute to the overall efficiency and effectiveness of the organization.• Lead and train the team by providing clear guidance, setting achievable goals, offering constructive feedback, and demonstrating best practices to foster a supportive and inclusive environment where members feel valued and motivated.
