The R&D Advanced Therapeutics Manager role is responsible for leading the development of advanced medical device reprocessing platforms, including Class III devices and complex electromechanical systems. This role provides both strategic and hands-on leadership across advanced therapeutic device reverse engineering and process development, with a focus on system-level architecture, disassembly/reassembly processes, component replacement strategies, and validation of functional equivalence.
Essential Duties and Responsibilities:
Strategic & Technical Leadership
- Define system-level architecture across different therapeutics platforms.
- Establish engineering requirements framework in compliance with FDA, ISO, and internal design controls.
- Define electrical performance criteria, functional equivalence requirements, and acceptance criteria for reprocessed devices.
- Lead cross-platform engineering strategy to ensure reuse of validation frameworks.
Advanced Reprocessing Development
- Develop and implement disassembly, component replacement, and reassembly strategies for complex devices.
- Lead reverse engineering and second-life device design approaches.
- Define critical-to-function components and replacement thresholds.
Validation & Test Architecture
- Build validation architecture covering:
- Electrical performance
- Mechanical performance
- System-level functional equivalence
- Oversee development of test methods, protocols, and design verification and validation strategies.
Program Execution
- Lead R&D programs from concept through production.
- Manage timelines, technical risk, and resource allocation.
- Partner with RA/QA to define regulatory pathways and validation expectations.
Team Development
- Lead, mentor, and develop engineering team (Sr Engineers, Engineers, Technicians).
- Support hiring strategy aligned with technical roadmap.
- Foster a collaborative, high-performance culture.
Supervisory Responsibilities:
• Direct supervision of R&D engineering team members
• Responsible for hiring, coaching, and performance management
Education, Qualifications and Skills:
• Bachelor's degree in engineering (Electrical, Mechanical, Biomedical or related); advanced degree preferred
• 8 - 10+ years of experience in medical device R&D
• Strong experience in Class III medical device development
• Experience with system-level architecture and electromechanical systems
• Deep understanding of design controls, risk management, and validation for FDA-regulated products
• Strong leadership, problem-solving, and communication skills
• Ability to work in a fast-paced, collaborative environment
