Engineering Intern - Instrument System

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions is seeking an Engineering Intern, this role will be part of the Instrument Systems team and will be reporting to the Manager of Verification and Validation. The Engineering Intern will be involved in projects supporting Systems Engineering, Verification and Validation, and Software Engineering (Cyber Security). The Engineering Intern will be engaged in verifying and validating product designs according to FDA requirements and internal quality standards. The incumbent will provide input to what is required to show compliance, including the amount of data required and the methodologies for collecting and analyzing the data. The incumbent ensures that the data is collected using devices and software of appropriate recorded configurations, performs the required analyses, and documents work to meet standards and project delivery commitments.

 

We are seeking undergraduate individuals in the Junior year or first semester of Senior year majoring in Software Engineering, Computer Science, Bioengineering with a focus on medical device software. Experience in Python language, C, C++ is a plus. 

 

Primary Responsibilities

• Works closely with Systems Engineering, Project Management, Marketing, Quality and Regulatory personnel to verify and validate products.
• Support drafting and execution of validation documentation

• Assist in defining and developing test systems in the lab. Ensure that all test systems and equipment are ap-appropriately validated and controlled.
• Assist with verification and validation testing of the system and its security features.
• Assist with Integration of Hardware, software and fluid subsystems into the overall in-vitro diagnostic system
• Support Updates to failure analysis and risk management documents based on integration data
• Assist with the reviewing and analyzing test data and record pass/fail results and conclusions. Ensure that testing and results are traced to requirements.
• Ability to track and report on progress toward completion of verification and validation.
• Assist with summarizing the verification and validation performed, the data reviewed, and conclusions reached.
• Project deliverables may include producing and/or reviewing verification and/or validation plans, protocols, and reports; execution of the plans and protocols; and resolving deviations.
• Able to adhere to timelines for verification and validation activities and provide updates to project teams.
• Support systems engineering teams in the completion of development testing, to characterize designs and understand trade-offs.
• Assist with verification and validation plans, protocols, and reports
• Assist in the review of cybersecurity design and architecture
• Successful execution of study protocols.

Conform to all cGMP requirements for documentation and data integrity

 

Education and Experience

Enrollment in a 4-year accredited degree program, working towards a BS in Mechanical, Manufacturing, Electrical, Software Engineering or other applicable degree.

•           Enrolled as an undergraduate in the Junior year or first semester of Senior year

•           Able to work 30 hours per week during the summer

•           Efficient and detail-oriented

•           Excellent analytical, problem-solving, decision-making skills

•           Excellent verbal and written communication skills

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