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.

Job Title: Associate Systems Engineer V&V

Department: Systems Engineering COE

Job Description:
Position Summary
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 daily. 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. Education and work experience should encompass a wide array of engineering disciplines relevant to: software testing, mechanical testing, system testing, material testing3rd party (agency) testing, and simulated use. The position will report to the Manager Systems Design Verification, Systems Engineering, Medical Devices R&D located at our great Software Center of Excellence in Aviacon, Tijuana.

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, Computer Science) discipline

• Advanced English: written and Verbal
• 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, Polarion, 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
• 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

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid