The Sr. Systems Engineer will be a technical lead in the design and development of Insulet's products. This position will be an integral member of the R&D team leading systems engineering activities while directly supporting the product development phases of Insulet's innovation pipeline of wearable pump technology. This role will dive into several aspects of Insulet's development processes including but not limited to defining product requirements, system integration, troubleshooting/design analysis, and design documentation.
Serve as the lead Systems Engineer of a cross-functional project team consisting of mechanical, electrical, software, manufacturing, and quality engineers to achieve program deliverables.
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 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.
Contribute to team goals by accomplishing related tasks as required.
Education and Experience
Education and Experience:
A Bachelor of Science or equivalent degree in Systems Engineering, Mechanical Engineering, Electrical Engineering or Biomedical Engineering is required, a Master of Science degree is desired; System Engineering training and/or certification is a plus.
A minimum of six (6) years' experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment.
2+ years of experience in leading a development/technical team.
Domain expertise in one of more associated domains; preferably Electrical or Mechanical Engineering, with exposure to Software, Quality, and Test Engineering
Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments
Comprehensive understanding of verification plans, protocols and reports in a regulated industry.
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
Experience or formal training in established Systems Engineering concepts.
Experience with long term R&D development programs (concept/feasibility, development, commercialization)
Experience with embedded software implementation, mobile technologies, wireless communications, IoT
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.
Physical Requirements (if applicable):