Sr. R&D Engineer

The Senior R&D Engineer role is responsible for designing, developing, validating, and implementing methods and processes to support advanced reprocessing of complex medical devices, including Class III systems and electromechanical platforms. This role will lead and contribute to projects focused on system-level performance, electrical validation, and device reconstruction, including disassembly, component replacement, and reassembly.

This role is expected to bring strong technical depth, hands-on engineering capability, and creative problem-solving to challenges in reverse engineering, system integration, and reprocessing technique development.

Essential Duties and 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, 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

Education, Qualifications and Skills:

• Bachelor's degree in engineering discipline (or equivalent experience)
• Minimum experience: 6 - 8+ years of experience
• Strong background in R&D with experience in electromechanical medical devices.
• Experience with various types of medical device design verification testing in accordance with FDA regulations: device functional performance, biocompatibility, sterilization, packaging, transportation simulation, real-time and accelerated aging, etc.
• Excellent technical writing skills and substantial experience writing test plans, protocols, and reports.
• Excellent problem-solving skills as well as 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) a plus.
• Ability to work in a fast-paced, collaborative team environment.
• Strong hands-on prototyping skills.
• Self-starter and highly motivated.
• Ability to have fun by motivating and encouraging other team members.