Systems Engineer (Hybrid - Acton, MA or San Diego, CA)

Insulet Corporation•San Diego, CA

1d•Hybrid

About The Position

The Systems Engineer 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, risk analysis, and system architecture documentation.

Requirements

Minimum Requirements Bachelor's Degree required (preferred field of study in Engineering including Biomedical, Electrical, Software, Mechanical)
A minimum of three (3) years’ experience (inclusive of any post-grad work) working on technical design or Systems Engineering in a multidisciplinary project team environment.
2+ years of experience in working on technical design
Domain expertise in one of more associated domains; preferably Electrical or Mechanical Engineering, with exposure to Software, Quality, and Test Engineering
Demonstrated understanding of Systems Engineering practices such as requirements management, risk analyses, design trade-off and cost-benefit analysis.
Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.
Ability to communicate at multiple levels of an organization
Ability to organize and judge priorities in a dynamic environment

Nice To Haves

Experience or formal training in established Systems Engineering concepts.
Experience with long term R&D development programs (concept/feasibility, development, commercialization)
Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS.
Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
Working knowledge of requirements lifecycle management tools (i.e. Helix ALM, Doors, Arena PLM)
Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market.
Experience with root cause analysis
Six sigma training / certification
Experience with software tools and coding (C++, JAVA, Android UI)
Experience with data analysis (Minitab, MatLAB)

Responsibilities

Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions.
Contribute to system development by defining system, subsystem architecture and design for manufacturing.
Identify and document system hazards, failure modes, and risk mitigations.
Work with the technical centers of excellence domain subject matter experts, and suppliers in the assessment, selection, integration, and qualification of key components and subsystems.
Serve as a technical consulting resource for integration, subsystem and system verification activities creating plans, protocols and reports as necessary.
Oversee engineering evaluations & data analysis reviews.
Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts of the design in compliance with FDA guidelines.
Support the preparation of proposals, program plans, estimates, and present information and status to leadership and other stakeholders.
Drive product investigations, using statistical analysis methodologies
Contribute to team goals by accomplishing related tasks as required.