Senior Systems Engineer

6 days ago

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Description

• The Senior Systems Engineer will be a technical lead in the design and development of Insulet’s products. • This position entails leading systems engineering activities within new product development projects. • 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 and subsystems. • Serve as a technical consulting resource for 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.

Requirements

• Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering is required. • A minimum of 8 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 cross-functional development team. • 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 writing verification plans, protocols and reports in a regulated industry. • Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls). • 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.