The Software Validation Engineer II assists/executes Software validation for Quality Management System's or Production Software.
Job duties:
- Generate Project Plans to identify strategies, roles/responsibilities, resource requirements, key milestones, timelines, etc.
for software validation projects.
- Follow SW validation procedure(s) to accomplish software validation or revalidation for Quality Management System (QMS) or Production Software (Equipment or Non-Equipment).
- Collaborate with business process owners to develop specifications for systems to meet business requirements.
- Work closely with the different teams involved to test the software provided by the vendor or in-house to verify it works as intended.
- Generate master validations plans for software projects.
- Generate/assist with risk assessments for software projects.
- Generate, execute, and/or review SW validation protocols (Operation/Performance qualification protocols) and reports (verifies test cases are adequate, verifies executed protocols for GDP, etc.)
- Coordinate user acceptance testing (UAT) activities and execution of validation protocols.
- Generate software data migration plans and reports.
- Generate software retirement plans and reports.
- Assist with code review and unit testing reports.
- Assist with training material and work instructions for users.
- Manage completion of projects per SW validation master plans and ensure timely completion.
- Serve as a PM for software validation projects.
- Derive solutions to challenges and escalate any issues as they are identified.
- Provide expertise to SW owners with regards to identifying required level of validation for SW items.
- Perform other duties and responsibilities as assigned.
**Qualifications**
- Bachelor's degree in Engineering or other relevant discipline or equivalent experience.
- Two (2) or more years of experience.
- Demonstrated experience in medical device manufacturing SW.
- English proficiency both written and verbal (80-85%).
- Working knowledge of General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV).
- Knowledge of 21CFR11, 21CFR820 and ISO 13485.
**Desired Qualifications**:
- Ability to translate regulation requirements into practical validation plans.
- Ability to write and review SW validation documentation (validation plan, risk assessment, user/functional requirements, protocols, reports, etc.)
- Keep abreast with regulatory requirements related to QMS software and production (non-equipment or equipment) software.
- Successful experience working independently, effectively, and confidently in a team environment.
- Ability to present SW validation strategies and obtain alignment from stakeholders (i.e.
upper management).
- Ability to determine the required test cases during SW validation.
- Demonstrated skills in developing risk-based master validation plans, test protocols, and preparing test reports.
- Knowledge of medical device software regulations, including requirements for electronic records and electronic signatures.
- Ability to work with multiple associates and prioritize projects to meet deadlines.
- Shows strong decision making and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficient with MS Project, Word, Excel, and Outlook.
**Posting Country**
Outside US