Principal R&D Engineer

Position Summary

The Principal R&D Engineer provides technical leadership for the development, verification, validation, and commercialization of Class II and Class III medical devices. This individual serves as a subject matter expert responsible for driving complex product development programs from concept through design transfer while ensuring compliance with applicable regulatory and quality requirements. The role partners closely with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, Clinical, Marketing, and Supply Chain to deliver innovative products that improve patient outcomes.

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.

Technical Competencies

• Design Controls
• Product Development Lifecycle (PLC)
• ISO 13485
• FDA Quality System Regulations
• ISO 14971 Risk Management
• Verification & Validation (V&V)
• Design Verification Testing
• Design Validation
• Root Cause Analysis
• CAPA
• Statistical Analysis
• Reliability Engineering
• DOE (Design of Experiments)
• GD&T
• Design for Manufacturability (DFM)
• Design Transfer
• Supplier Development
• Technical Documentation