R&D Advanced Therapeutics Manager- Relocation Assistance Provided
On-siteScottsdale, Arizona, United States
Job Summary
Define system-level architecture and establish engineering requirements for advanced medical device reprocessing platforms in compliance with FDA, ISO, and internal design controls. Lead reverse engineering, disassembly, and reassembly strategies for complex electromechanical systems while developing validation architectures for electrical, mechanical, and functional equivalence. Manage R&D programs from concept through production, overseeing timelines, technical risks, and resource allocation alongside regulatory pathway definitions. Direct supervision of engineering team members, including hiring, coaching, and performance management within a collaborative environment.
Required Qualifications
- 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
Desired Qualifications
- advanced degree
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