Job DescriptionWe are looking for a talented Senior Software Validation Engineer to help us continue producing quality output. The Senior Software Validation Engineer is responsible to work collaboratively with Software and Process Teams and will apply Quality methodologies and processes to make sure deliverables meet company's highest standards. The position requires a candidate with a Masters in Engineering or related field, with 3 years of medical device quality experience or a Bachelor's Degree in these fields with 5+ years of experience.Job ResponsibilitiesAssist with the development of software validation requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are metEvaluate proposed changes to validated computer systems and recommend level of validation activities requiredIdentify and qualify all computer systems which impact operations using a risk based methodologyDevelop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation planDevelop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plansExecution of validation plans and validation documentsBe highly motivated, organized, and able to manage priorities QualificationsMinimum of 5 years of experience in medical device computer software validationExperienced in 21 CFR 11 standard within a medical product development environmentExperienced in Good Documentation PracticesMinimum Bachelors in Engineering or equivalent, advanced degree (Masters) preferredAdditional InformationSenseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits.