Senior Manager, Product and Technology Development

Who Our Client Is:

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.

What Our Client Needs:

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.

What You'll Do:

• 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

What You'll Need:

• 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 capabilities
• PMP certification or significant experience in structured project management methodologies is highly desired
• Experience managing global teams is a plus

What They Offer:

• On-site role in Franklin, TN
• A 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.