Principal R&D Engineer

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

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