Risk Management Quality Engineering Intern

Werfen • Bedford, MA

22h • $22 - $30

About The Position

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.

What This Job Offers

• Career Level: Intern