• Job Description

  Req#: 11089BR
  Develop/execute strategies and procedures for Software validation. Responsible for defining, analyzing, and implementing hardware and system requirements based on the company’s Quality Management System. Job duties:
  • Develop strategies for continuous improvement to the SW lifecycle program to ensure improved compliance to regulations (e.g., identify which procedures are required, high level summary of the required sequence of events, 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.
  • 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 ensures timely completion. Maintain frequent communication with stakeholders and manager regarding project status.
  • Review and approve SW validation protocols and reports (e.g., verify test cases are adequate, verify executed protocols for GDP, etc.)
  • Provide technical direction to junior level Software Validation Engineers.
  • Aid in developing automation, including automation of PLM and MES software testing and quality system processes.
  • 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.
  • Provide software (e.g., SAP, PLM, MES) training to users within the organization after receiving training from the implementation vendors.
  • Question current methods while evaluating broad implications to develop practical improvements; focus on achieving goals.
  • Successfully lead large size projects.
  • Provide solutions to complex technical issues associated with specific projects.
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  • Perform additional duties as assigned.
  1. Bachelor’s degree in IT, Engineering, or other relevant discipline.
  2. Minimum six (6) to eight (8) years of professional experience validating engineering software applications.
  3. Able to work independently and with minimal guidance to perform required tasks.
  4. Experience with software regulations, including involvement with electronic records and electronic signatures.
  5. Experience with Software Development Life Cycle of controlled systems.
  6. Demonstrated experience in medical device Manufacturing software and Quality.
  7. Management software
  8. Successful experience working independently, effectively, and confidently in a team environment.
  9. Excellent written and verbal communication skills.
  10. Working knowledge of General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV).
  11. Understands advanced business principals.
  12. Proficient with MS Office, including Word, Excel, Outlook, and Teams.
  Desired Qualifications
  1. Ability to present SW validation strategies and obtain alignment from stakeholders (e.g., upper management).
  2. Excellent knowledge of medical device software regulations, including requirements for electronic records and electronic signatures.
  3. Good time management abilities.
  4. Understanding of computer system and manufacturing validation processes.
  5. Ability to translate regulation requirements into practical validation plans.
  6. Ability to write, review, and approve SW validation protocols and reports.
  7. Skills in documenting complex procedures and troubleshooting procedures related to systems.

• About the company

  A 360-Degree Approach to Neuroendovascular Therapy

Notice