Senior Medical Device R&D Engineer - Reprocessing & Validation

Innovative Health LLC; Scottsdale (AZ); On-site; USD 120,000 - 180,000; Full time

Job summary

Innovative Health LLC in Scottsdale, AZ is seeking a Senior R&D Engineer responsible for designing, developing, validating, and implementing methods for advanced reprocessing of complex medical devices, including Class III systems. The role requires strong hands-on engineering and leadership to support system-level performance and reconstruction tasks.

You will lead cross-functional efforts with software, electrical, mechanical, and manufacturing teams, conduct electrical and mechanical

Qualifications

• Bachelor's degree in engineering or equivalent experience.
• Minimum 6–8+ years of experience in R&D with electromechanical medical devices.
• Experience with FDA and ISO design verification testing and regulatory requirements.
• Strong ability to write test plans, protocols, and reports.
• Knowledge of Design Controls, Risk Management, statistics, Engineering Principles, Test Method Development, Test Method Validation (Gage R&R), and Design Verification / Validation.

Responsibilities

• Lead development of advanced medical device reprocessing solutions in compliance with design controls and FDA/ISO requirements.
• Design, develop, and implement test systems, fixtures, and instrumentation (electrical, mechanical, and automated systems).
• Support system-level validation strategy, including design verification and validation planning.
• Lead or contribute to disassembly, component replacement, and reassembly strategies for complex devices.
• Perform root cause analysis and failure investigations related to electrical, mechanical, or material degradation.
• Collaborate with cross-functional teams (software, electrical, mechanical, manufacturing) to coordinate and oversee test sample builds.
• Develop and analyze performance data and degradation trends across reuse cycles.
• Use SolidWorks (or similar tools) to design test fixtures, tooling, for devices as needed.
• Serve as a cross-functional team member for various project-related activities.
• Assist or lead process improvement projects to optimize cost, throughput, and quality.
• Assist with DFMEA and PFMEA risk assessments.
• Compile project status updates and present to senior management.
• Comply with company policies and procedures.
• Focus on delivering products to support the R&D project pipeline.
• Provide technical leadership and mentorship to junior engineers and technicians.

Skills

Hands-on prototyping

Problem solving

Technical writing

Self-starter

Team collaboration

Education

Bachelor's degree in engineering

Tools

SolidWorks

Job description

Innovative Health LLC in Scottsdale, AZ is seeking a Senior R&D Engineer responsible for designing, developing, validating, and implementing methods for advanced reprocessing of complex medical devices, including Class III systems. The role requires strong hands-on engineering and leadership to support system-level performance and reconstruction tasks.

You will lead cross-functional efforts with software, electrical, mechanical, and manufacturing teams, conduct electrical and mechanical