Senior Software Validation Engineer
- Germantown, MD, USA
Come be a part of the company that is transforming the way diabetes care is being delivered to patients across the globe!
Senseonics, maker of the first and only 90-day continuous glucose monitoring (CGM) implantable sensor (Eversense), is looking for people to create excitement and drive adoption for this new, life-changing technology. Eversense, our Continuous Glucose Monitoring System, is designed to be the first fully implantable continuous glucose monitoring system that is highly accurate and stable throughout its long sensor life and will enable people with diabetes to live their lives with ease!
We 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 Bachelor’s Degree in Engineering or related field, with 3 years of medical device quality experience.
- Assist with the development of software validation requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met
- Evaluate proposed changes to validated computer systems and recommend level of validation activities required
- Identify and qualify all computer systems which impact operations using a risk based methodology
- Develop 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 plan
- Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
- Execution of validation plans and validation documents
- Be highly motivated, organized, and able to manage priorities
- Minimum of 3 years of experience in medical device computer software validation
- Experienced in 21 CFR 11 standard within a medical product development environment
- Experienced in Good Documentation Practices
- Minimum Bachelors in Engineering or equivalent, advanced degree (Masters) preferred
Senseonics 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.