Principal R&D Technician

The Principal R&D Technician is a senior-level technical contributor responsible for supporting the design, development, testing, and commercialization of Class III medical devices in a regulated product development environment. This role partners closely with R&D Engineering, Quality, Manufacturing, Clinical, and Regulatory teams to build, test, troubleshoot, and document complex electromechanical and/or catheter-based medical devices throughout the product lifecycle.

The ideal candidate brings deep hands-on technical expertise, strong problem-solving skills, and extensive experience working under FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and design control requirements. The Principal R&D Technician serves as a technical leader within the laboratory and prototyping environment and may mentor junior technicians while driving best practices in product development and testing.

Essential Duties and Responsibilities

• Build, assemble, modify, and troubleshoot Class III medical device prototypes, fixtures, and test systems.
• Execute engineering tests, verification activities, and characterization studies in accordance with approved protocols and procedures.
• Support design verification (DV), design validation (PV), reliability, and bench testing activities.
• Collaborate with R&D engineers to refine designs for manufacturability, reliability, and performance.
• Maintain accurate and compliant documentation including test records, build histories, protocols, reports, and lab notebooks in accordance with design control requirements.
• Operate and maintain laboratory equipment, instrumentation, and test systems.
• Assist in root cause investigations, failure analysis, and corrective/preventive action activities.
• Develop and improve laboratory methods, tooling, fixtures, and prototype assembly processes.
• Coordinate prototype builds and support pilot manufacturing activities as needed.
• Ensure compliance with GMP, GDP, EHS, and company quality standards.
• Identify opportunities for process improvement and laboratory efficiency enhancements.
• Provide technical guidance and mentorship to junior technicians and cross-functional team members.
• Support supplier evaluations, component testing, and incoming material assessments when applicable.
• Participate in risk management activities including FMEA development and hazard analysis support.
• May support preclinical, sterilization, packaging, and environmental testing activities.

Required Qualifications

• Associate’s degree in Engineering Technology, Biomedical Technology, Electronics, Mechanical Technology, or related technical discipline; equivalent combination of education and experience may be considered.
• 10 years of hands-on experience in medical device R&D or product development, including significant experience supporting Class III medical devices.
• Strong understanding of FDA design controls, GMP, ISO 13485, and regulated product development processes.
• Demonstrated expertise in prototype assembly, debugging, and test execution.
• Experience working with complex electromechanical, disposable, catheter-based, implantable, or minimally invasive medical devices.
• Ability to read and interpret engineering drawings, schematics, assembly instructions, and test procedures.
• Proficiency with laboratory equipment such as oscilloscopes, multimeters, force testers, pressure systems, microscopes, and data acquisition systems.
• Strong technical documentation and organizational skills.
• Excellent troubleshooting and analytical problem-solving abilities.
• Ability to work independently with minimal supervision in a fast-paced R&D environment.

Preferred Qualifications

• Experience supporting cardiovascular, neurovascular, electrophysiology, implantable, robotic, or surgical device programs.
• Familiarity with statistical analysis tools and DOE methodologies.
• Experience with SolidWorks, CAD tools, or fixture design.
• Knowledge of sterilization methods, biocompatibility, and packaging validation processes.
• Experience supporting transfer to manufacturing and pilot line development.
• Lean manufacturing or Six Sigma certification is a plus.