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 field7+ years of product development experience in the medical device industryStrong background in design controls, test method development, and materials / process selectionSkilled in CAD (SolidWorks), lab tools, and statistical methodsProven leadership and cross-functional team management experienceWorking knowledge of applicable U.S. and international medical device standardsPreferred :
Expertise in catheter or minimally invasive device design and fabricationExperience from concept through commercializationStrong project management and mentoring capabilities