MicroVention Terumo

Job Description

Develop/execute strategies and procedures for software (SW) validation. Manage the Software Lifecycle program. 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, including, but 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.
• 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.).
• Ensure software lifecycle program complies with applicable regulatory requirements including requirements for electronic records and electronic signatures.
• 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.

Auto req ID

12847BR

Location

Alajuela, Costa Rica

Department Name

3211-CR-Quality

Qualifications

1. Bachelor’s degree in IT, Engineering, or other relevant discipline.
2. A minimum of two (2) years professional experience validating engineering software applications.
3. Demonstrated experience in medical device manufacturing SW and Quality Management SW.
4. Demonstrated experience in medical product quality assurance.
5. Demonstrated skills in developing risk-based master validation plans, test protocols, and preparing test reports.
6. Demonstrated skills in project management.
7. Successful experience working with others on software application projects.
8. Successful experience working independently, effectively, and confidently in a team environment.
9. Working knowledge of General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV).
10. Working knowledge of AAMI TIR36, 21CFR11, GAMP 5, 21CFR820, IEC 62304, ISO 14971, ANSI/AAMI/IEC 62304, ANSI/AAMI/IEC TIR80002-1, AAMI TIR45.
11. Working knowledge of Guidance for Industry, FDA Reviewers and Compliance on OTS SW Use in Medical Devices.
12. Excellent written and verbal communication skills.
13. Proficient with MS Project, Word, Excel, Teams, and Outlook.

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 (e.g., 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.

External-Facing Title

Engineer II, Software Validation - CR

Posting Country

Outside US