Senior Manager, Product and Technology Development

Senior Manager, Product and Technology Development Our client is a company in the therapeutic apheresis and cell therapy technology space. Its R&D organization is responsible for executing a product, technology and innovation roadmap, taking products from concept through commercialization. Our client is seeking a Senior Manager, Product and Technology Development to serve as a senior leader within R&D, based on-site in Franklin, TN. This person will directly manage a cross-functional team of up to 10 engineers spanning mechanical, electrical, software, and biomedical disciplines, and will own end-to-end product lifecycle management. The role drives advancements in therapeutic apheresis and cell therapy technology and calls for a leader who combines team leadership, execution focus, engineering discipline, and a passion for innovation. Lead, mentor, and develop a cross-functional team of up to 10 engineers to execute the product innovation roadmap Provide guidance on complex engineering challenges across mechanical, electrical, software, and biomedical domains Plan, prioritize, and manage engineering projects from concept to completion, using tools like Smartsheet to deliver on time, within scope, and on budget Lead the development lifecycle of Class II/III medical devices, including concept, design, development, verification/validation, and transfer to manufacturing Oversee design control processes in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations Foster a culture of design excellence, design reliability/risk management, and continuous improvement Drive intellectual property generation and contribute to a strong, defensible patent portfolio Partner with Regulatory Affairs, Quality Assurance, Marketing, and Operations to align development activities with business and compliance requirements Monitor emerging technologies, market trends, and the competitive landscape to identify innovation opportunities Bachelor's degree in engineering (Mechanical, Electrical, Software, Biomedical Sciences, or a related field); MS/MBA a plus 7+ years of experience in medical device product development, with at least 3 years in leadership roles Demonstrated success developing and launching Class II/III FDA-regulated medical devices, including in EU MDR environments Strong knowledge of design controls (ISO 13485), DHF, risk management, MDR regulation, and usability engineering Strong leadership, communication, and stakeholder management skills Excellent problem-solving skills with hands-on execution capabilitiesPMP certification or significant experience in structured project management methodologies is highly desired Experience managing global teams is a plus On-site role in Franklin, TNA senior leadership position directly managing a cross-functional team of up to 10 engineers Competitive salary and benefits package Opportunities for professional development and career growth. Collaborative and innovative work environment.