Principal R&D Engineer Job San Francisco area,California USA,Engineering

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