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.
