08 Apr
Software Validation Analyst - IEC 62304
Arizona, Scottsdale , 85260 Scottsdale USA

job summary:

Job Summary:In this role, you will be responsible for providing software leadership that is influential and collaborative with new product development and software maintenance project teams. The primary focus is to support the on-time delivery of software development efforts that contribute to high quality, compliant, regulated devices available to the global market. This position also supports the maintenance and improvement of the software development processes. location: Scottsdale, Arizonajob type: Permanentwork hours: 8am to 5pmeducation: Bachelors responsibilities:

Essential Duties and Responsibilities:
  • Lead and support all facets of software engineering through stages of software product lifecycle (Design, Verification and Validation Testing, Release, and Post-Market) for the software for medical devices.
  • Support cybersecurity team in conducting security review, updating and maintaining security policy and procedure to meet relevant industry standards and regulations (HIPAA, GDPR, HITRUST, etc.)
  • Provide software process leadership and guidance supporting product development.
  • Use subject matter expertise in support of key technical reviews covering product Design, Development and Planning.
  • Support internal and third-party audits of the software development processes.

Basic Qualifications:
  • Bachelor's degree in: Computer Science, Software Engineering, or related field.
  • Minimum 5 years of experience in a software development environment, with technical software engineering experience (design, coding, testing).
  • Experience with Software Quality and Risk Management standards in medical devices, such as: IEC 62304, FDA 21 CFR 820, ISO 13485, and ISO 14971.
  • Software development or software engineering experience with medical or other regulated devices.

Preferred Knowledge, Skills and Abilities:
  • Defect tracking and metrics
  • Automated testing tools for continuous integration
  • Development of embedded software and custom electronics
  • Integrating software, electronic hardware, and mechanical subsystems
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target

Travel Requirements: Must be able to travel up to 10% of the time when Covid passes qualifications:
  • Experience level: Experienced
  • Minimum 5 years of experience
  • Education: Bachelors
skills:
  • Software Development
  • Embedded Coding
  • SOFTWARE ENGINEER
  • Software Assurance
  • Quality (5 years of experience is preferred)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.


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