Medical Device Software Quality Engineer
- Ceevra
- San Francisco, CA, USA
Job Description
Position Summary:
As a Medical Device Software Quality Engineer, your primary job focus will be designing, implementing, and extending the medical device quality processes for Ceevra software that generates and displays 3D models of patient anatomy.
Local candidates are preferred, although we’ll consider highly qualified remote candidates. If local, we envision 3 days/week in our SF offices (or more if preferred by the candidate).
Responsibilities
- Drive quality-focused design and development of Ceevra software, including defining appropriate requirements, and creating and executing verification and validation plans and protocols
- Maintain and extend Ceevra’s Quality Management System
- Oversee various quality management activities, such as management reviews, internal audits, and external audits
- Develop quality practices applicable to cutting edge technologies with evolving regulatory guidelines such as Machine Learning
Requirements
- At least three years experience as a medical device quality engineer, with at least one year focused medical device software
- Familiarity with relevant standards (ISO 13485, IEC 62304, FDA QSR and/or CE MDR)
- Experience with medical imaging is a plus
- BS in a relevant STEM field
Apply Now
Ceevra is a San Francisco-based, medical software company that helps surgeons (mainly cancer surgeons) plan and operate better through advanced imaging. We take standard CT scans and MRIs and transform them into brilliant, interactive 3D digital models which are viewed by surgeons from their mobile phones, tablets, or through robotic surgery platforms. We help surgeons determine the best type of operation to perform and the best way to perform it – resulting in faster operations, reduced hospital stay, saved organs, and reduced cancer recurrence. A quick explainer video: vimeo.com/441446067
Ceevra’s product is FDA-cleared and has been the centerpiece of two successful, multi-center, randomized clinical trials. Our customers include two of the ten largest health systems in the country, and several leading academic medical centers. We are privately held, and our team is highly cohesive and collaborative.
Ceevra is rapidly expanding our engineering team. We offer candidates the unique opportunity to work on cutting edge technology and a product that helps improve and prolong the lives of cancer patients, while doing so at a small and growing startup that serves some of the country’s most innovative medical centers.