Associate Director, Device Tech Transfer

Provide program leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally. Develop and execute strategic plans for technology transfer. Utilize extensive experience in design controls, device transfer, control strategies device risk management, and design verification testing. Author and complete regulatory filing sections, respond to questions and pre-approval inspections from a product development standpoint. Secure early sponsorship and stakeholder alignment for projects and initiatives. Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance. Requirements Technical BS degree or higher 10+ years of experience in medical device or combination product engineering Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product manufacturing Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation Exceptional project management skills Experience collaborating with combination product development teams and working groups Core Competencies Demonstrates expertise in medical device and combination product engineering, with a strong focus on technology transfer, design controls, and regulatory compliance. Proven ability to lead projects, ensure stakeholder alignment, and maintain high safety and quality standards. Highest-signal resume keywords Technical BS Degree or Higher 10+ Years Experience in Medical Device Engineering Technical Leadership in Technology Transfer Design Controls and Risk Analysis Expertise Exceptional Project Management Skills ATS Optimization Keywords Hard Skills Design Controls Device Transfer Control Strategies Device Risk Management Design Verification Testing Process Validation Regulatory Filing Technical Leadership Technology Transfer Collaboration with Development Teams Soft Skills Project Management Stakeholder Alignment Communication Industry Keywords Medical Devices Combination Products Regulatory Compliance Quality Assurance Product Development #J-18808-Ljbffr Jobtailor