About the role

Senior Systems Engineer leading design and development of wearable medical devices for Insulet. Collaborating with cross-functional teams to achieve project deliverables and support innovation pipeline.

Responsibilities

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 technical consultant for integration, subsystem and system verification activities creating plans, protocols and reports, as necessary.
Create and maintain traceability among design input, design output, design 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.
Serve as technical consultant for software development deliverables, such as design/architecture documents, requirements and failure mode analysis.
Participate in Agile ceremonies, such as Program Increment (PI) Planning, Retrospectives, Inspect and Adapt.
Provide guidance and support to junior engineers, promoting knowledge sharing and professional development.

Bachelor’s degree in systems, Biomedical, Electrical, Computer Engineering/Science or related field (or equivalent experience).
A minimum of 3 to 7+ years of 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.
Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments.
Experience with long term R&D development programs (concept/feasibility, development, commercialization).
Experience in application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors).
Experience with root cause analysis and troubleshooting.
Experience writing verification plans, protocols and reports in a regulated industry.
Experience with data analysis (Minitab, JMP, or MatLAB).
Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).