Principal R&D Engineer

Job Description

Overview:

Seeking a Principal R&D Engineer to lead medical device product development from concept through commercialization. This role drives cross-functional teams, mentors engineers, and plays a strategic role in shaping both products and processes.

Responsibilities:

• Lead design and development of new devices in alignment with quality system and regulatory requirements
• Translate user needs into validated designs with clear specifications and robust test methods
• Oversee verification, validation, and design transfer activities
• Guide design reviews and ensure timely completion of deliverables
• Manage multiple projects and act as primary technical contact for leadership
• Mentor engineers and potentially supervise direct reports
• Collaborate with physicians, suppliers, and cross-functional teams
• Identify department-level process improvements and contribute to product strategy
• Support product line extensions and continuous improvement initiatives

Qualifications:

• Bachelor’s degree in Engineering or related field
• 7+ years of product development experience in the medical device industry
• Strong background in design controls, test method development, and materials/process selection
• Skilled in CAD (SolidWorks), lab tools, and statistical methods
• Proven leadership and cross-functional team management experience
• Working knowledge of applicable U.S. and international medical device standards

:

• Expertise in catheter or minimally invasive device design and fabrication
• Experience from concept through commercialization
• Strong project management and mentoring capabilities