This Principal Engineer will provide lead technical support on the development of micro-surgical system.
- New product development for medical devices and surgical instrumentation (including knowledge of microsurgical instrumentation)
- Develops medical devices in accordance with 21CFR Part 820 and ISO 13485 design control requirements
- Catheter design, prototype development, material selection, bench testing and manufacturing techniques
- Identifying user needs, verifying and validating designs, and strong understanding of design failure modes
- Understanding of various types of mechanisms, materials, proper tolerancing, drafting standards, design for manufacturing and GD&T
- Member of Change Control Board (CCB) responsible for conducting design and documents change impact assessments
- Member of Material Review Board (MRB) responsible for the investigation, corrective action, and dispositioning of product nonconformances
- Responsible for customer complaint investigations and recommending corrective actions
- Ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/or teams
- Ability to review and critically assess patents and other forms of intellectual property
- Contribute to the development and innovation of future surgical technologies
- BS/MS in Biomedical Engineering or Mechanical Engineering.
- Experience in ophthalmology and/or cell & gene therapy experience is highly preferable.
- 7-10 years of medical device product development experience
- Refined communication and interpersonal skills, with deep experience working effectively with cross-functional teams
- Ability to understand and simplify complex scientific concepts into core business and development objectives
- Demonstrated ability to build internal relationships