-Developing marketing strategies to promote new products in order to gain market share-Establishing strategic partnerships with suppliers, manufacturers, and other industry experts in order to develop new products or improve existing products-Managing a team of designers, engineers, marketers, and other staff to develop new products-Creating business cases for new products based on research and market analysis-Developing a product roadmap with specific goals and milestones that align with the organization’s strategic objectives-Managing the development of new products from concept to commercialization-Conducting market research to identify new product opportunities that meet customer needs-Preparing budgets for product development projects and managing expenses throughout the process-Ensuring that products meet federal safety standards, including those for environmental impact and human health

Product Development Manager Responsibilities:● Led the end-to-end product development lifecycle for multiple Class 2 medical devices, from concept to commercialization, ensuring adherence to quality standards, regulatory requirements, and project timelines.● Managed and coordinated cross-functional teams, including R&D, QC, engineering & manufacturing, to drive product development projects and achieve key milestones.● Conducted market research and analysis to identify customer needs, market trends, and competitivelandscape, providing valuable insights for product planning and strategy.● Defined product requirements, specifications, and design inputs based on customer needs and regulatory requirements.● Collaborated with industrial designers and engineers to develop product concepts, prototypes, and detailed designs, optimizing usability, functionality, and manufacturability.● Implemented and managed project management methodologies, ensuring effective project planning, resource allocation, risk management, and issue resolution.● Oversaw verification and validation activities, including design verification testing, usability testing, and clinical evaluations, to ensure product safety and efficacy.● Successfully launched several new medical devices, achieving commercial success and driving revenuegrowth.Quality Manager Responsibilities:● Develop and implement quality assurance policies and procedures to ensure compliance with FDA regulations and ISO standards.● Lead a team of quality engineers and technicians to conduct audits, inspections, and testing of medical devices throughout the manufacturing process.● Successfully led the company through FDA inspections with zero major findings.● Implemented a robust supplier qualification program, resulting in improved supplier performance and reduced non-conformances.● Developed and delivered training programs on QMS and regulatory requirements to enhance employee awareness and compliance.

● Conducted inspections and testing of incoming raw materials, components, and finished products to ensurecompliance with specifications and quality standards.● Utilized PLC (Programmable Logic Controller) experience to perform automated testing, manufacturing anddata analysis for quality control purposes.● Implemented Lean Six Sigma methodologies to identify process inefficiencies and drive continuousimprovement initiatives.● Participated in the development and validation of test methods and protocols for product verification andvalidation.● Assisted in the investigation of customer complaints and non-conformance issues, identifying root causes andimplementing corrective actions.● Collaborated with the manufacturing team to implement process improvements, resulting in increased productquality and efficiency.● Contributed to the successful launch of several new medical devices by providing quality engineering supportthroughout the product development lifecycle, including design control activities.

I developed and implemented engaging STEM lessons for high school students, which included a focus on project-based learning. I leveraged core teaching methods and materials: visual aids, real-world examples, and practice problems to engage students in learning• Taught a group of academic failure students to fall in love with STEM and achieve academic success.