Systems Test Engineer Intern at Tandem… · Californi…

Summary: Tandem Diabetes Care creates innovative solutions for diabetes management and is seeking a Systems Test Engineer Intern. This role involves technical contributions to testing, analysis, and documentation of medical device systems, ensuring compliance with design controls and performance verification. Responsibilities: - Works within design controls and contributes to the design history file for medical devices by verifying the product performance with formal test methods, protocols, and reports - Evaluates development plans and design changes to components for their impact to integrated systems testing and test equipment - Participates in the verification of prototype components and systems - Designs and runs experiments, analyzes, and summarizes data, and reports the results and conclusions - Develops test methods and verifies performance with Gage R&R studies - Participates in reviews of requirements, designs, data, and design verification protocols/reports - Recommends selection of test equipment based on analysis of requirements and component specifications - Participates in evaluating the reliability of materials, components, and systems - Supports systems engineering testing and troubleshooting of new and existing products - Develops and manages development and testing at external test facilities/vendors - Participates in product and process risk assessments and mitigations - Completes required training plan before assuming job responsibilities - Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements - Other responsibilities as assigned Required Qualifications: - Pursuing bachelor's degree in mechanical engineering, electrical engineering, biomedical engineering, computer engineering or related field or equivalent combination of education and applicable job experience - Ability to communicate technical knowledge to varying levels within an organization - Exposure to testing methodology and data collection in a development environment is valuable - Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information - Excellent written communication skills and experience with MS Office - Capable of using statistical techniques and tools to summarize data and support conclusions - Able to work effectively in a team environment at all levels within the organization - Able to alter behavior and opinions in light of new information - Has working knowledge of federal and other regulations, e.g., QSRs, ISO 14971 IEC 60601 series - Knowledge of Good Documentation Practices (GDP) - Ability to use SolidWorks to create and modify engineering models and drawings Preferred Qualifications: - Entry level, experience in the medical device field preferred Required Skills: Testing Methodology, Data Collection, Statistical Techniques, Documentation Practices (GDP), Regulatory Knowledge - QSRs, Regulatory Knowledge - ISO 14971, Regulatory Knowledge - IEC 60601, SolidWorks, Persuasion Benefits: Competitive compensation package that includes bonus, Robust benefits package