May 02, 2022

Medical Device Software Quality Engineer

$90,000 - $125,000 yearly
  • Ceevra
  • San Francisco, CA, USA
Full time Machine Learning Quality Regulatory Software

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

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