Associate Systems Engineer assisting in system integration and product lifecycle activities at Insulet. Collaborating with cross-functional teams to ensure quality and compliance in medical device design.
Responsibilities
Support the definition, integration, and characterization of innovative product content
Engage and actively contribute to system engineering activities within Life Cycle Engineering
Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement
Collaborate with cross-functional project teams to achieve project deliverables
Contribute to design changes for subsystems including requirement refinement, risk reviews, risk mitigations, and system verification plans
Support functional analysis, timeline analysis, and detailed trade-off studies
Contribute to troubleshooting system-level issues and root cause analysis
Contribute to risk management activities, including hazard identification and FMEA
Work closely with regulatory affairs and quality assurance teams for regulatory submissions
Author engineering build requests and design protocols
Requirements
Bachelor degree required (preferred field of study: Biomedical, Electrical, Mechanical, Systems)
1+ years of experience working in the medical device industry/ high regulated product development industry
1+ years of experience working directly in a Systems Engineering discipline within product development
Demonstrates working knowledge of engineering principles and scientific methods
Hands-on and inquisitive, not being afraid to challenge a design
General understanding of medical devices and regulations
Planning and organization skills
Ability to organize and judge priorities in a dynamic environment
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