Position Overview

The Sr. Software Validation Engineer develops strategies and procedures for Software validation. Manages the Software Life-cycle program. Typical job duties include:
  • Develop strategies for continuous improvement to the SW life-cycle program, to ensure improved compliance to regulations (i.e. identify which procedures are required, high level summary of the required sequence of events, etc.)
  • Generate Master Project Plans to identify strategies, roles/responsibilities, resource requirements, key milestones, timelines, etc.
  • Develop 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.
  • Manage completion of projects per SW validation master plans, and ensure timely completion. Maintain frequent communication with stakeholders and manager, regarding project status.
  • Derive solutions to challenges and escalate any issues as they are identified.
  • Designate cross-functional 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.
  • Review, and approve SW validation protocols and reports (verify test cases are adequate, verify executed protocols for GDP, etc.)
  • Ensures software life-cycle program complies with applicable regulatory requirements including requirements for electronic records and electronic signatures.
  • May provide advice or consultancy with respect to international regulations and guidelines in the area of quality assurance for computer systems.
  • Performs other duties and responsibilities as assigned.
    • Must have a Bachelor’s degree in IT, Engineering or other relevant discipline.
    • Must have five (5) or more years of experience in project management.
    • Must have five (5) or more years of experience validating software applications.
    • Must have five (5) or more years of experience in medical device software regulations, including involvement with electronic records and electronic signatures.
    • Working knowledge of General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV).
    • Working knowledge of AAMI TIR36, 21CFR11, GAMP 5, 21CFR820, IEC 62304, ISO 14971, ANSI/AAMI/IEC 62304, ANSI/AAMI/IEC TIR80002-1, AAMI TIR45.
    • Working knowledge of Guidance for Industry, FDA Reviewers and Compliance on OTS SW Use in Medical Devices.

    Desired Qualifications
    • Successfully manage large projects with the ability to motivate cross-functional teams to complete their assigned tasks.
    • PMP certification desired, but not required.
    • Demonstrated experience in medical device manufacturing SW and Quality Management SW.
    • Successful experience working with others on software application projects.
    • Successful experience working independently, effectively and confidently in a team environment.
    • Ability to work with multiple associates and prioritize projects to meet deadlines.
    • Ability to present SW validation strategies and obtain alignment from stakeholders (i.e. upper management).
    • Excellent written and verbal communication skills.
    • Proficient with MS Project, Word, Excel, Outlook.
    • Demonstrated experience in medical product quality assurance.
    • Excellent knowledge of medical device software regulations, including requirements for electronic records and electronic signatures.
    • Demonstrated skills in developing risk-based master validation plans, test protocols, and preparing test reports.
    • Ability to translate regulation requirements into practical validation plans.
    • Ability to write, review, and approve SW validation protocols and reports.
    • Ability to determine the required test cases during SW validation.
    • Demonstrated skills in project management.