Systems Engineering Manager leading a team to optimize i3D.net’s global infrastructure solutions. Focused on collaboration and innovation for real - time system efficiency and scalability.
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.
Requirements
- 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).
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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