Principal R&D Engineer

Key Responsibilities: Lead the technical development of new medical device products, platforms, and technologies from concept through commercialization. Serve as the technical lead for complex, high-visibility product development projects. Develop product requirements, design inputs, engineering specifications, and technical documentation. Drive risk management activities including hazard analyses, DFMEA, PFMEA, and risk-benefit assessments. Design and execute product verification and validation strategies, including protocol development and technical report generation. Support human factors, usability engineering, and design validation activities. Lead root cause investigations, troubleshooting efforts, and design improvements for existing products. Apply Design Controls in accordance with FDA 21 CFR Part 820, ISO 13485, and applicable international standards. Collaborate with manufacturing teams during process development, qualification, and design transfer activities. Drive product reliability, robustness, and manufacturability improvements using Design for Manufacturability (DFM) and Design for Assembly (DFA) principles. Interface with suppliers and external development partners to support component development and technology integration. Support regulatory submissions, technical files, and audit readiness activities. Analyze experimental data and utilize statistical methods to support engineering decisions. Mentor and provide technical guidance to engineers across multiple disciplines and experience levels. Lead technical reviews and present project updates to senior leadership.

Required Qualifications: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Chemical Engineering, or related engineering discipline.10+ years of medical device product development experience. Demonstrated experience leading complex product development programs within a regulated medical device environment. Strong knowledge of Design Controls and product development processes. Experience with risk management methodologies including ISO 14971 and FMEA.Proven experience authoring and reviewing verification and validation protocols and reports. Experience supporting regulatory submissions and compliance activities. Strong analytical, problem-solving, and technical leadership skills. Experience working within FDA-regulated and ISO 13485-certified environments. Excellent communication and cross-functional leadership capabilities.

Preferred Qualifications: Master's degree or Ph.D. in an engineering discipline. Experience with implantable, cardiovascular, structural heart, electrophysiology, neuromodulation, or other Class III medical devices. Experience with catheter-based delivery systems and combination products. Knowledge of materials engineering, finite element analysis (FEA), computational modeling, or biomechanics. Six Sigma Green Belt, Black Belt, or equivalent continuous improvement certification. Experience with human factors engineering and usability studies. Experience supporting global product launches and international regulatory submissions.