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.

• 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.

• 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.

• Familiarity with statistical analysis tools and DOE methodologies.
• Experience with Solid Works, 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.