R&D Advanced Therapeutics Manager- Relocation Assistance Provided

Innovative Health LLC•Scottsdale, AZ

About The Position

The R&D Advanced Therapeutics Manager leads development of advanced medical device reprocessing platforms, including Class III devices and complex electromechanical systems. The role provides strategic and hands-on leadership in advanced therapeutic device reverse engineering and process development, emphasizing system-level architecture, disassembly and reassembly processes, component replacement strategies, and validation of functional equivalence. Relocation assistance is provided. The manager leads R&D programs from concept through production, managing timelines, technical risk, and resource allocation. The role partners with Regulatory Affairs and Quality Assurance to define regulatory pathways and validation expectations, and directly supervises, hires, coaches, and manages the performance of engineering team members, including senior engineers, engineers, and technicians.

Requirements

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

Responsibilities

Define system-level architecture across 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 reuse 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, managing timelines, technical risk, and resource allocation.
Partner with Regulatory Affairs and Quality Assurance to define regulatory pathways and validation expectations.
Directly supervise, hire, coach, and manage the performance of R&D engineering team members.
Mentor and develop engineers and technicians.
Support hiring strategy aligned with the technical roadmap.
Foster a collaborative, high-performance culture.