Position Overview

Provide technical leadership and high level of expertise to engineers and process owners in developing and executing strategies/procedures for validation of software systems used in medical device manufacturing and software in a medical device in order to comply with corporate procedures and applicable regulations.

  • Develop strategies for continuous improvement to the software (SW) lifecycle program, to ensure improved compliance to regulations.

  • Develop and enhance SW validation procedure(s) for manufacturing equipment and processes and for software in a device to ensure alignment with appropriate regulatory requirements. This includes SW validation request processes, SW categorization procedures, risk assessment procedures, test protocol templates, change control documents, etc.

  • Lead, define, and analyze system and software requirements and input/output processes by using current engineering methods and technologies.

  • Manage completion of projects per SW validation master plans and ensure timely completion.

  • Maintain frequent communication with stakeholders and manager regarding project status. Develop strategic solutions to challenges encountered during project execution.

  • Review and approve SW validation documentation including risk assessments, requirements documentation, protocols, and reports (e.g., verify test cases are adequate, verify executed protocols for GDP, etc.)

  • Provide technical leadership to software validation engineer(s) during projects and tasks.

  • Ensure software lifecycle program complies with applicable regulatory requirements including requirements for electronic records and electronic signatures.

  • Demonstrate effective communication style working with all levels of organizational structure through multiple departments and across global sites.

  • Represent software validation program during inspections / audits by regulatory authorities and during internal audits.

  • Perform additional duties as assigned.

    • Bachelor’s degree in IT, Engineering, or other relevant discipline or equivalent combination of education and experience

    • Minimum of ten (10) to twelve (12) years of professional experience in validating manufacturing-related software applications (equipment and non-equipment) and software in a device in regulated medical device environment.

    • Expertise of medical device software regulations, including requirements for electronic records and electronic signatures, including Expertise of General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV), IEC 62304, 21 CFR Part 820, 21 CFR Part 11, AAMI TIR36

    • Ability to support and develop software validation team by providing technical leadership and coaching.

    • Ability to translate regulation requirements into practical validation plans.

    • Ability to work cross-functionally with process owners and provide guidance during computer system validation (CSV) life cycle.

    • Expertise with Software Development Life Cycle of controlled systems

    • Ability to successfully motivate cross-functional teams to complete their assigned tasks.

    • Ability to effectively work independently, as well as in a team environment.

    • Strong written and verbal communication skills

    • Proficient with MS Office, including Word, Excel, Outlook, and Teams

      What sets you apart:

    • Advanced degree (e.g., master’s degree) in IT, Engineering, or other relevant discipline or equivalent combination of education and experience

    • Ability to present SW validation strategies and obtain alignment from stakeholders. (e.g., upper management)

    • Understanding of medical device manufacturing and QC processes

    • Experience defending computerized software validation program during inspections by regulatory authorities.