Principal Product Development Engineer in Miami,FL,US

Role Overview Our client is seeking a Principal Product Development Engineer to join their team in Miami, FL. This is a full time, on site position within a fast paced, early stage medical device environment. This role is ideal for an experienced engineer who thrives in high intensity settings and can take full ownership of projects from concept through commercialization. The position requires navigating ambiguity, overcoming technical challenges, and maintaining momentum in resource constrained environments. The ideal candidate is highly self directed, resilient, and driven to solve complex engineering problems. Key Responsibilities Lead the design, development, and optimization of new and existing medical devices Own product development efforts from initial concept through prototyping, testing, and commercialization Drive research and development initiatives in technically complex environments Develop innovative engineering solutions that align with clinical and market needs Oversee prototyping, validation, and testing activities to ensure product performance and quality Collaborate cross functionally with engineering, manufacturing, and regulatory teams Ensure designs are cost effective, manufacturable, and compliant with applicable standards Identify, assess, and mitigate product design risks throughout the development lifecycle Manage timelines, priorities, and deliverables in a fast paced setting Qualifications Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field Strong background in mechanical engineering with expertise in product design using SolidWorks CAD Proven experience leading product development from concept through regulatory submission or commercial launch, preferably in a startup or fast paced environment Demonstrated success leading R D initiatives in high accountability, technically demanding settings Ability to remain composed and effective under pressure, tight timelines, and shifting priorities Strong sense of ownership with a bias toward action and independent execution Excellent analytical and problem solving skills, including data driven decision making Experience identifying and mitigating design risks, with understanding of manufacturing processes Working knowledge of medical device regulations and standards such as ISO 13485 and

FDA 21 CFR

Part 820 Strong communication skills and ability to collaborate across cross functional teams Preferred Qualifications Experience in catheter or vascular access product development