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
FAQs
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