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
