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