Associate Systems Engineer, V&V (Hybrid) Tijuana (Hybrid)

Job Summary

The Associate Systems Engineer will support the development of Insulet's wearable medical devices by collaborating with cross-functional R&D teams throughout the product development lifecycle. This role offers hands-on exposure to systems engineering activities including requirements development, design verification, troubleshooting, feasibility testing, engineering documentation, and regulatory-driven design control processes.

The Associate Systems 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:

• BS in an Engineering (Biomedical, Electrical, Computer Science, etc ) discipline

• Ability to work in a fast paced, dynamic environment with a passion for continuous learning

• Passionate about improving the lives of others

• Technical writing ability

• Experience with lab equipment (testing)

• Microsoft office suite (Word, Excel, PowerPoint)

• Effective communication skills

Preferred Skills and Competencies:

• 1-2 yrs experience as a Systems/Project Engineer in the Medical Device or other regulated industry and/or equivalent

• Demonstrated working knowledge of engineering principles and scientific methods.

• General understanding of communication, mobile technology, IoT (Internet of Things); a strong plus

• Experience with software / product lifecycle tools – Jira, Helix, Bamboo, Bitbucket; a strong plus.

• Hands-on and inquisitive, not being afraid to challenge a design

• General understanding of medical devices & regulations

• Experience with data analysis (MatLAB)

• Planning and organization skills

• Experience with SolidWorks or Pro-Engineer

• Ability to organize and judge priorities in a dynamic environment

Physical Requirements (if applicable):

• Must be able to sit or stand for 8 hours a day

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.