Analyst – Product Validation

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Location: Yorba Linda, CA US
Job Category: Quality & Regulatory Affairs
Position Description
Analyst – Product Validation

As a Product Validation Analyst, you will be responsible for clinical validation of software, hardware, and computer systems.

The clinical area(s) you will support: Pulmonary Function Testing and Cardiopulmonary Exercise Testing. (Ideally including support of Sleep Diagnostics and Therapy) RPFT, CPFT, or Exercise Physiologist with PFT experience. RPSGT (beneficial).

In particular you can expect to:

  • Define clinical use-cases and translate those into testable protocols for software and hardware testing.
  • Perform clinical validation of pulmonary and sleep systems including regular bio-cals for quality control purposes.
  • Provide clinical input and perspective on projects including risk assessments.
  • Provide support, both internal/external to resolve clinical and technical issues as needed.
  • Review clinical requirements and define, develop, & write test plans.
  • Regularly communicate with the development team to ensure the validity of defects and conformance with operator/patient needs.
  • Author validation plans, protocols, reports, and traceability matrixes.

You will have the opportunity to:

  • Improve patient outcomes
  • Meaningfully impact the company’s short-term and long-term success
  • Work closely with executives across the organization
  • Grow your role as you see fit
  • Learn everything there is to know about respiratory medical device manufacturing
  • Create an inspiring workplace

To be successful, you will need:

  • 2+ years of related work experience.
  • Ability to understand abstract requirements and assess vulnerabilities in proposed solutions.
  • Hard working, driven, ability to adapt to an ever-changing environment.
  • Effective time management skills in order to work within schedules established for software development turnaround times.
  • Practical experience of risk based test approach and requirements traceability.
  • Good analytical skills.
  • Experience with Windows OS including troubleshooting, security, and administration desirable.
  • Experience with automated testing desirable.
  • Experience testing in an agile environment desirable.
  • Excellent written and verbal communication skills and interpersonal skills; attention to detail.

Education:

  • Bachelor’s degree or equivalent experience in related field required.

Some Logistics:

The current office is based in Yorba Linda however we will be moving to the Irvine area. Once property is identified in Irvine, this position will relocate to the new space based in the Irvine area.

 

Yorba Linda - Savi Ranch
Full time
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