Sr. R&D Engineer

About the Role

This position leads the design, development, validation, and implementation of advanced reprocessing methods for complex medical devices, including Class III systems and electromechanical platforms. The role focuses on system-level performance, electrical validation, and device reconstruction (disassembly, component replacement, and reassembly). It requires strong technical expertise, hands-on engineering skills, and creative problem-solving in reverse engineering, system integration, and reprocessing technique development.

Responsibilities

• Lead development of advanced medical device reprocessing solutions in compliance with design controls and applicable FDA and 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 and 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.

Clinical Support Responsibilities

• Attend clinical cases for learning, device launch, and troubleshooting.
• Interact with clinicians and field personnel to understand clinical needs and provide technical support.
• Develop and maintain a deep understanding of medical device reprocessing techniques, including cleaning, sterilization, and biocompatibility requirements.
• Develop and maintain relationships with key opinion leaders and clinical partners.

Medical Device Reprocessing Responsibilities

• Support advanced reprocessing approaches.
• Develop and optimize reprocessing methods for single-use and complex electromechanical medical devices.
• Conduct performance, biocompatibility, and sterilization testing on reprocessed devices.
• Ensure compliance with all regulatory requirements for medical device reprocessing.
• Participate in cross-functional teams to introduce reprocessed devices into production.

Supervisory Responsibilities

• Provide mentoring and guidance to R&D team members.
• May supervise and manage the work of junior engineers and technicians.

Requirements

• Bachelor's degree in engineering discipline (or equivalent experience).
• Minimum of 6–8+ years of experience.
• Strong background in R&D with experience in electromechanical medical devices.
• Experience with medical device design verification testing in accordance with FDA regulations, including:
  • Device functional performance
  • Biocompatibility
  • Sterilization
  • Packaging
  • Transportation simulation
  • Real-time and accelerated aging
• Excellent technical writing skills and substantial experience writing test plans, protocols, and reports.
• Strong problem-solving skills and keen analytical abilities.
• Knowledge of Design Controls, Risk Management, Statistics, Engineering Principles, Test Method Development, Test Method Validation (Gage R&R), and Design Verification/Validation.
• Proficiency in CAD design and drafting (SolidWorks preferred).
• Ability to work in a fast-paced, collaborative team environment.
• Strong hands-on prototyping skills.
• Self-starter and highly motivated.
• Ability to motivate and encourage other team members.