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Staff Systems Engineer
| Company | Insulet Corporation |
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| Location | Massachusetts, USA |
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| Salary | $124350 – $186525 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior, Expert or higher |
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Requirements
- Bachelor of Science or equivalent experience in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering, or relevant field
- 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 or 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.
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 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.
Preferred Qualifications
- Master of Science degree is desired; System Engineering training and/or certification is a plus
- Experience or formal training in established Systems Engineering concepts
- Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS
- Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market.
