06 ago
|
Insulet
|
Tijuana
The Associate Quality Engineer position is designed to provide the selected candidate with a broad exposure to the design and development process for wearable medical devices that are used by patients around the world on a daily basis. This position will be an integral member of the R&D; team directly supporting the product development phases of Insulet’s innovation pipeline of wearable pump technology. This role will provide exposure to several aspects of Insulet’s design control processes including but not limited to writing and interpreting product requirements, device integration, verification test methods, troubleshooting/design analysis, and design documentation.
Responsibilities
Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement.
Support all phases of the design and development lifecycle of a medical device
Participate in product design or technical reviews.
Author and review Engineering Change Orders.
Author engineering build requests with direct responsibility for managing engineering materials.
Design and set up feasibility tests in a lab environment.
Author design feasibility protocols and reports.
Participate in product design, technical reviews, and triage brainstorming sessions.
Design verification testing execution in support of design improvements, FDA and international clearance, or commercial release.
Contribute to team goals by accomplishing related tasks as required
Education and Experience:
Minimum Requirements
BS in an Engineering (Biomedical, Electrical, Industrial) discipline (Prefered)
Ability to work in a fast paced, dynamic environment with a passion for continuous learning
Advanced English
Passionate about improving the lives of others
Technical writing ability
Microsoft office suite (Word, Excel, PowerPoint)
Effective communication skills
Preferred Skills and Competencies:
1-2 yrs experience as a Quality/Project Engineer in the Medical Device or other regulated industry and/or equival
📌 Quality Engineer (Tijuana)
🏢 Insulet
📍 Tijuana