Senior Validation Engineer

Alphatec Spine
Carlsbad, CA
Job Description
The Sr. Validation Engineer is an advanced role responsible for creating, planning, and executing complex software verification activities, and contributing to continuous improvement and validation processes.

Requirements

  • Understanding of FDA Quality System Regulations (21 CFR Part 820) & ISO 13485
  • Understanding of IEC 62304 and IEC 60601 standards
  • Understanding of ISO 14971 risk management requirements
  • Familiarity with defect tracking and test management tools (e.g., Jira, Polarion)
  • Working knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) and competency using desktop lab equipment (function generators, oscilloscopes, etc.)
  • Working knowledge of Statistical Process Control (SPC), Design of Experiments (DOE), and probability/statistics concepts
  • Background supporting regulatory submissions such as 510(k)s
  • Strong project management skills to coordinate complex, cross-functional projects
  • Ability to communicate technical concepts effectively with internal and external stakeholders, including executive management
  • Detail-oriented, deadline-driven, and able to work collaboratively in a team environment

Benefits

  • Medical, dental and vision insurance
  • 401(k) or other retirement savings plan
  • Paid time off
  • Other benefits
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