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

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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