Senior R&D Engineer
Claria Medical is a Series A-stage medical device start-up developing minimally invasive surgical tools for hysterectomy, one of the most common surgical procedures for women. Our early accomplishments have resulted in a “Safer Technologies Designation” from the FDA. In addition to private financing, we have been awarded prestigious National Science Foundation and National Institute of Health grants. Perhaps most importantly we are passionate about developing best-in-class treatments to address unmet needs in women’s healthcare. We are a small but growing group looking for superstars to add to the team!
As part of the R&D team you will help drive our first-generation system through clinical studies and various bench and laboratory experiments. In parallel, you will begin development of a second-generation system intended to address different clinical indications. Additionally, you will participate in drafting our formal FDA application/responses and prepare our products for commercialization. You will collaborate with key groups involved in an early-stage start-up: Contract Manufacturers, Electrical/Software Engineering, Quality, Clinical, Regulatory, Intellectual Property, and you will likely attend/present at Board of Director meetings.
You should have most of the following skills /experience / knowledge and will learn the new skills as necessary:
Experience designing products from initial sketches through prototyping, tooling and high-volume manufacturing
A strong understanding of Materials and Manufacturing Processes, including: design for injection molding, design for machining, design for 3D printing
Experience incorporating optics into designs
Good workshop / machine shop skills
Simple mechatronics design, including simple programming (Arduino / Raspberry Pi) and prototyping of circuits
Experience designing and building manual and semi-automated test fixtures
Experience developing and executing process validations and test method validations
Significant experience developing medical devices in compliance with ISO 13485, including generating high quality documentation of your designs and experiments
Understanding the necessity of writing detailed, high-quality R&D documentation that satisfies the requirements of a well-designed QMS framework.
Significant experience carrying out risk management activities in compliance with ISO 14971
Strong SolidWorks skills
Preferred Education and Job Experience:
A Bachelor’s Degree or Master’s Degree in Mechanical or Biomedical Engineering
A minimum of 7 years of experience in Medical Device Research and Development
Mountain View, CA. (This is an in-person / on-site position)
How to Apply:
Please submit a resume and short cover letter or email describing why this job opportunity might be a good fit for both of us! Email to email@example.com