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

Preferred Qualifications

  • 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

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