Position Overview

The Software Validation Engineer develops/executes strategies and procedures for Software validation. Manages the Software Lifecycle program. Job duties:
  • Develops strategies for continuous improvement to the SW lifecycle program, to ensure improved compliance to regulations (i.e. identify which procedures are required, high level summary of the required sequence of events, etc.)
  • Generates Master Project Plans to identify strategies, roles/responsibilities, resource requirements, key milestones, timelines, etc.
  • Develops SW validation procedure(s) as needed to ensure alignment with appropriate regulatory requirements. This includes, but is not limited to, SOPs, forms, SW categorization procedures, risk assessment procedures, change control documents, etc.
  • Manages completion of projects per SW validation master plans and ensures timely completion. Maintains frequent communication with stakeholders and manager regarding project status.
  • Derives solutions to challenges and escalates any issues as they are identified.
  • Works with software owners to generate and maintain master SW list(s).
  • Provides expertise to SW owners with regards to identifying required level of validation for SW items.
  • Reviews and approves SW validation protocols and reports (verifies test cases are adequate, verifies executed protocols for GDP, etc.)
  • Ensures software lifecycle program complies with applicable regulatory requirements including requirements for electronic records and electronic signatures.
  • Performs other duties and responsibilities as assigned.

    1. Bachelor’s degree in IT, Engineering or other relevant discipline or equivalent experience.
    2. Minimum three (3) or more years of experience in project management.
    3. Minimum three (3) or more years of experience validating software applications.
    4. Minimum three (3) or more years of experience in medical device software. regulations, including involvement with electronic records and electronic signatures.
    5. Successfully manage/execute large projects with the ability to motivate cross-functional teams to complete their assigned tasks.
    6. Demonstrated experience in medical device manufacturing SW and Quality Management SW.
    7. Demonstrated experience in medical product quality assurance.
    8. Demonstrated skills in developing risk-based master validation plans, test protocols, and preparing test reports.
    9. Demonstrated skills in project management.
    10. Successful experience working with others on software application projects.
    11. Successful experience working independently, effectively and confidently in a team environment.
    12. Working knowledge of General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV).
    13. Working knowledge of AAMI TIR36, 21CFR11, GAMP 5, 21CFR820, IEC 62304, ISO 14971, ANSI/AAMI/IEC 62304, ANSI/AAMI/IEC TIR80002-1, AAMI TIR45.
    14. Working knowledge of Guidance for Industry, FDA Reviewers and Compliance on OTS SW Use in Medical Devices.
    Desired Qualifications
    1. Ability to work with multiple associates and prioritize projects to meet deadlines.
    2. Ability to present SW validation strategies and obtain alignment from stakeholders (i.e. upper management).
    3. Excellent knowledge of medical device software regulations, including requirements for electronic records and electronic signatures.
    4. Ability to translate regulation requirements into practical validation plans.
    5. Ability to write, review, and approve SW validation protocols and reports.
    6. Ability to determine the required test cases during SW validation.
    7. PMP certification desired, but not required.
    8. Excellent written and verbal communication skills.
    9. Proficient with MS Project, Word, Excel, Outlook.