Insulet Corporation Sr. Systems Engineer in Billerica, Massachusetts
The Senior Systems Engineer will be a lead design engineer responsible for the technical design and development of Insulet’s products. Education and work experience should encompass a vast array of engineering disciplines to include, software, communications, electrical, mechanical, and materials.
The Position will report to the Systems COE Leader, Advanced Technology & Engineering located at Insulet’s Headquarters in Billerica, MA.
Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables
Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions
Contribute to system development by defining system and subsystem architectures
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
Lead integration, subsystem and system verification activities creating plans, protocols and reports as necessary.
Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file.
Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders.
Perform other duties as required.
Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering is required, a Master of Science degree is desired; Systems Engineering training and/or certification is a plus
Minimum of 5 – 10 years’ experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment
Domain expertise in one of more associated domains; preferably Electrical or Software Engineering, with exposure to Mechanical, 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
Experience working in a medical devices and highly regulated product development environment
Prefer experience with design and development processes that conform to standards such as ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971
- Demonstrated skills in developing and introducing innovative FDA regulated medical devices (Class 1, 2 or 3) and related Design controls.
Skills and Competencies
Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs but adaptive to address business and market needs
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/procurement/manufacturing/regulatory and quality expert
External Company Name: Insulet Corporation
External Company URL: http://www.myomnipod.com/