Position Overview

Manage the development of strategies and procedures for Software validation. Manage the Software Lifecycle program and leads the validation activities. Job duties:
  • Manage development of strategies for continuous improvement to the Software (SW) Lifecycle program to ensure continued compliance to regulations.
  • Manage team to generate of Master Project Plans to identify strategies, roles/responsibilities, resource requirements, key milestones, timelines, etc.
  • Manage the development of SW validation procedure(s) as needed to ensure alignment with appropriate regulatory requirements. This includes, but is not limited to, SOPs and work instructions for software validation master plans, risk assessments, software requirements, traceability matrices, test protocols, test reports, forms, change control documents, etc.
  • Manage timely completion of projects per SW validation master plans.
  • Identify areas of opportunity, derive solutions, and manage completion of said solutions.
  • Supervise direct report(s) and teams to carry out required SW validation activities per master plans.
  • Work with software owners to generate and maintain master SW list(s).
  • Provide expertise to SW owners with regards to identifying required level of validation for SW items.
  • Provide review of SW validation documentation to ensure procedures and regulatory requirements are met.
  • Perform other duties and responsibilities as assigned.

    1. Bachelor’s degree in IT, Engineering, or other relevant discipline or equivalent combination of education and experience.
    2. A minimum of one (1) year of supervisory or management experience/responsibility.
    3. A minimum of six (6) years of experience in project management,validating software applications, andmedical device software regulations, including involvement with electronic records and electronic signatures.
    4. Expertise in General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV).
    5. Expertise in AAMI TIR36, 21CFR11, GAMP 5, 21CFR820, IEC 62304, ISO 14971, ANSI/AAMI/IEC 62304, ANSI/AAMI/IEC TIR80002-1, AAMI TIR45.
    6. Expertise in Guidance for Industry, FDA Reviewers and Compliance on OTS SW Used in Medical Devices.
    7. Demonstrated experience managing large projects with the ability to motivate direct reports and cross-functional teams to complete their assigned tasks.
    8. Demonstrated experience in medical device manufacturing SW validation.
    9. Demonstrated experience managing teams to successfully complete SW validation initiatives.
    10. Ability to work with multiple associates and teams and ability to prioritize projects to meet deadlines.
    11. Ability to develop SW validation strategies and present and obtain alignment from stakeholders (e.g., upper management).
    12. Excellent written and verbal communication skills.
    13. Proficient with MS Project, Teams, Word, Excel, and Outlook.
    14. Demonstrated experience defending SW validation procedures and validations during audits/inspections by regulatory bodies.
    15. Excellent knowledge of medical device software regulations, including requirements for electronic records and electronic signatures.
    16. Ability to translate regulation requirements into practical procedures and validation templates.
    Desired Qualifications
    1. PMP certification desired.
    2. Advanced degree in IT, Engineering, or other relevant discipline.
    3. Software Quality Engineer Certification (ASQ).