Intellectt Inc

Software Validation Engineer

Intellectt Inc Irvine, CA
Intellectt Inc

Software Validation Engineer

Intellectt Inc Irvine, CA
4 months ago 73 applicants

See who Intellectt Inc has hired for this role

Role: Software Validation Engineer

Location: Irvine, CA - 92614

Duration: 6 Months

Job Description

  • Investigate complex product / non-product software quality and compliance issues (e.g. software deviations/failures) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
  • Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects / systems / test equipment in partnership with cross-functional teams; provide recommendations for improvements.
  • Develop complex software documentation (e.g. Protocols, Reports, Hazard Analysis) for product or non-product software validation deliverables utilizing engineering knowledge.
  • Collaborate with stakeholders on the Code Review process for product software or custom manufacturing test equipment.
  • Perform dry-runs and execution of Software Validation Protocols.
  • Train, coach, and guide other employees on software documentation.
  • Other Incidental duties as required.

Required Skills:

  • Proven expertise in usage of MS Office Suite;
  • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
  • Working knowledge and understanding of statistical techniques.
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software.
  • Substantial knowledge of business acumen products and software technologies
  • Strong problem-solving, organizational, analytical and critical thinking skills
  • Substantial understanding of processes and equipment used in assigned work
  • Good leadership skills and ability to influence change
  • Knowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment or product software).
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education/Experience:

  • Bachelor's degree in engineering required.
  • 2-4 years experience required.
  • Previous experience with software verification and validation activities in a medical device industry.

  • Seniority level

    Entry level

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Staffing and Recruiting

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