The Executive Director, Product & Technology Development, is a senior leader within the R&D organization responsible for shaping and executing the company’s product, technology and innovation roadmap. This role will lead end-to-end product lifecycle management, from concept through commercialization and will lead engineering & technology teams focused on delivering breakthrough solutions in the life sciences & technology space. The ideal candidate combines Leadership, strategic vision, technical expertise, and a passion for innovation to ensure our product portfolio & innovation team remains competitive, customer-focused, forward-thinking & future ready. This role reports to the Chief Innovation Officer.
Education:
- Bachelor’s degree in engineering, Biomedical Sciences, or a related field (Master’s or Ph.D. preferred).
Experience:
- 12+ years of experience in medical device product development, with at least 5 years in leadership roles.
- Demonstrated success in developing & launching class II/III FDA-regulated medical devices as well as EU MDR environment.
- Experience managing global teams a plus.
Skills & Competencies:
- In-depth knowledge of design controls (ISO 13485), DHF, risk management and usability engineering.
- Strong leadership, communication, and stakeholder management skills.
- Strategic thinker with hands-on execution capabilities.
- PMP certification or experience in structured project management methodologies is highly desired.
- Define and execute the product development strategy aligned with company goals and market needs.
- Collaborate with executive leadership to establish the product roadmap and innovation pipeline.
- 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.
- Build, mentor, and lead a high-performing multi-disciplinary team, including engineers, program managers, and scientists.
- Drive performance through clear objectives, accountability, and professional development.
- Partner with Regulatory Affairs, Quality Assurance, Clinical, Marketing, and Operations to align development activities with business and compliance requirements.
- Ensure effective design transfer and scale-up into manufacturing.
- Monitor emerging technologies, market trends, and competitive landscape to identify innovation opportunities.
- Engage with key opinion leaders (KOLs), customers, and stakeholders to translate clinical needs into product solutions.
- Competitive salary and benefits package
- Opportunities for professional development and career growth.
- Collaborative and innovative work environment.
Working Conditions: Office based role in Nashville/Franklin TN area
Travel Expectations: 30%