Senior Manager, Product & Technology Development

Therakos • Nashville, TN

3d

About The Position

The Senior Manager, Product & Technology Development is a senior leader within the R&D organization responsible for executing the company’s product, technology, and innovation roadmap. The role directly manages a cross-functional team of up to 10 engineers across mechanical, electrical, software, and biomedical disciplines, focusing on end-to-end product lifecycle management. From concept through commercialization, the leader drives advancements in therapeutic apheresis and cell therapy technology. The position combines project and team leadership, execution focus, engineering discipline, and a passion for innovation.

The role leads the development lifecycle of Class II/III medical devices, including concept, design, development, verification and validation, and transfer to manufacturing. It oversees design controls and regulatory compliance, drives design excellence and continuous improvement, and partners with Regulatory Affairs, Quality Assurance, Marketing, and Operations to align development with business and compliance requirements. The position also supports intellectual property generation, manufacturing scale-up, and identification of innovation opportunities.

Requirements

• Bachelor’s degree in engineering, such as Mechanical, Electrical, Software, Biomedical Sciences, or a related field.
• At least 7 years of experience in medical device product development.
• At least 3 years in leadership roles.
• Demonstrated success developing and launching Class II/III FDA-regulated medical devices and working in an EU MDR environment.
• Strong knowledge of design controls, ISO 13485, Design History Files (DHF), risk management, MDR regulation, and usability engineering.
• Strong leadership, communication, and stakeholder management skills.
• Excellent problem-solving skills and hands-on execution capabilities.

Nice To Haves

• Master’s degree or MBA.
• Experience managing global teams.
• PMP certification or significant experience with structured project management methodologies.

Responsibilities

• 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 such as Smartsheet to deliver on time, within scope, and within budget.
• Lead the development lifecycle of Class II/III medical devices, including concept, design, development, verification and 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 performance through clear objectives, accountability, and professional development.
• Drive intellectual property generation and contribute to a strong, defensible patent portfolio.
• Partner with and act as a liaison to Regulatory Affairs, Quality Assurance, 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 the competitive landscape to identify innovation opportunities.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional development and career growth.
• Collaborative and innovative work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior