Overview
The Lead Product Engineer is a senior-level role responsible for driving strategies and creating innovative private-label medical products. This position oversees the full product lifecycle, including customer insights, design, testing, competitive benchmarking, regulatory compliance, and quality assurance.
Key Responsibilities
* Product Strategy & Ideation: Conduct market and competitive analyses, define product specifications, and lead user research to identify customer needs.
* Development & Testing: Guide product roadmaps, evaluate new technologies, and manage vendor collaborations. Develop testing protocols to ensure product quality, safety, and regulatory compliance (FDA, ISO standards).
* Team Collaboration: Work closely with cross-functional teams in marketing, sourcing, product management, sales, and quality to align goals and deliver cost-effective, innovative solutions.
* Documentation & Compliance: Manage design history files, risk assessments, and regulatory documentation for new product launches.
Qualifications
* Bachelor’s degree in Engineering, Sciences, or related field (Master’s/Doctorate preferred).
* 10+ years of experience in product engineering, development, or management.
* Strong skills in problem-solving, data analysis, and project management.
* Experience with design tools (e.g., SolidWorks, Matlab) and medical device regulations.
* Ability to travel up to 20% and work onsite in Richmond, VA as needed.
Preferred Experience
* Knowledge of medical devices (e.g., IV therapy, wound care, surgical kits).
* Application of VOC tools and Six Sigma practices.
* Demonstrated success in product innovation within healthcare or related industries.
This role is ideal for a collaborative, innovative engineer with a passion for improving healthcare through product development.
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