Risk Management Quality Engineering Intern
About The Position
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview: The purpose of the internship is to provide meaningful professional hands-on experience to students with leadership potential and proven academic performance. Werfen hires students majoring in Engineering and Life Sciences fields into this internship program based on business need. Ideal candidates will combine technical and business knowledge with analytical strength and creative problem-solving abilities. Position Description Join our Quality Engineering team and gain hands-on experience in risk management for medical devices. This internship focuses on applying ISO 14971 risk management principle throughout the product lifecycle, ensuring patient safety and compliance with global regulatory standards. In this position you will be involved in the day-to-day activities of the Quality team including collaboration with cross-functional teams to identify, evaluate, and control risks of medical devices. We expect the intern to gain an in-depth knowledge of the product and its operation while participating in the creation and maintenance of risk management documentation for software enabled electromechanical medical devices.
Requirements
- Currently pursuing B.S. in Engineering with a minimum of 2 college semesters complete.
- Ability to multitask.
Nice To Haves
- Familiarity with Failure Mode and Effects Analysis (FMEA) for the systematic assessment of how product failures may introduce hazards and hazardous situations.
- Knowledge of probability and statistics for interpreting test results and reliability data
- Strong problem-solving skills with an aptitude for quantitative analysis to aid in risk-based decision making.
- Requires confidence in using Microsoft Office Suite and other software applications.
- Requires Enthusiasm, motivation, initiative and ability to work within an interactive and energetic workplace.
Responsibilities
- Collaboration with cross-functional teams to identify, evaluate, and control risks of medical devices.
- Participating in the creation and maintenance of risk management documentation for software enabled electromechanical medical devices.
- Review process procedures, change orders, equipment specifications, validation plans, and reports.
- Assistance in creating, reviewing and maintaining Product Risk Management Files.
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What This Job Offers
Career Level
Intern
