Werfen · 3 hours ago
Risk Management Quality Engineering Intern
US-MA-Bedford
Internship
Onsite
Intern
$22/hr - $30/hrWerfen is a growing, family-owned company and a worldwide leader in specialized diagnostics. The internship provides hands-on experience in risk management for medical devices, focusing on applying ISO 14971 principles and collaborating with cross-functional teams to ensure patient safety and compliance with regulatory standards.
Health CareHospitalManufacturingMedical Device
Responsibilities
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
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
Review process procedures, change orders, equipment specifications, validation plans, and reports
Assistance in creating, reviewing and maintaining Product Risk Management Files
Qualification
Required
Currently pursuing B.S. in Engineering with a minimum of 2 college semesters complete
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
Ability to multitask
Company
Werfen
Werfen is a developer, manufacturer and distributer of IVD testing solutions.
Founded in 1966
5001-10000 employees
H1B Sponsorship
Werfen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Dominique Petitgenet
Chief Operating Officer, Transfusion & Transplant
Ken Vogel, HCS
Human Resources Business Partner
Recent News
MarketScreener
2025-12-17
2025-12-08
Company data provided by crunchbase