R&D Advanced Therapeutics Manager- Relocation Assistance Provided

Innovative Health•Scottsdale, AZ

About The Position

The R&D Advanced Therapeutics Manager leads the development of advanced medical device reprocessing platforms, including Class III devices and complex electromechanical systems. The role combines strategic and hands-on leadership in advanced therapeutic device reverse engineering and process development, with emphasis on system-level architecture, disassembly and reassembly processes, component replacement strategies, and validation of functional equivalence. The manager defines engineering requirements and performance criteria, develops reprocessing and validation approaches, and leads R&D programs from concept through production. The role also partners with Regulatory Affairs and Quality Assurance on regulatory pathways and validation expectations, and leads, mentors, hires, and manages an R&D engineering team.

Requirements

Bachelor's degree in Electrical, Mechanical, Biomedical, or related engineering field.
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.

Nice To Haves

Advanced degree preferred.

Responsibilities

Define system-level architecture across different therapeutics platforms.
Establish an engineering requirements framework compliant 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 enable reuse of validation frameworks.
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.
Build validation architecture covering electrical performance, mechanical performance, and system-level functional equivalence.
Oversee development of test methods, protocols, and design verification and validation strategies.
Lead R&D programs from concept through production.
Manage program timelines, technical risk, and resource allocation.
Partner with Regulatory Affairs and Quality Assurance to define regulatory pathways and validation expectations.
Lead, mentor, and develop engineering team members, including Senior Engineers, Engineers, and Technicians.
Support hiring strategy aligned with the technical roadmap.
Foster a collaborative, high-performance culture.
Directly supervise R&D engineering team members.
Hire, coach, and manage performance.