Principal Engineer

Onsite Services Philadelphia, Pennsylvania

This Principal Engineer will provide lead technical support on the development of micro-surgical system.
Responsibilities:

  • 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

Experience:

  • 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