The Sr. Systems Engineer will be a technical lead in the design and development of Insulet's products. This position entails leading systems engineering activities and working cross functionally within new product development projects. 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 Sr. Manager of Systems Engineering Programs, located at Insulet's Headquarters in Acton, Massachusetts.
* 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. * Conduct engineering evaluations & data analysis reviews. * 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. * Contribute to team goals by accomplishing related tasks as required.
Education and Experience
* A 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; System Engineering training and/or certification is a plus. * A minimum of six (6) 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 * Comprehensive understanding of verification plans, protocols and reports in a regulated industry. * 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. * Ability to communicate at multiple levels of an organization * Ability to organize and judge priorities in a dynamic environment
* Experience or formal training in established Systems Engineering concepts. * Experience with software based applications and code management tools (C++, JAVA, Bamboo, Bitbucket, JIRA) * Experience with device to device communication means (i.e. RF, BLE) * Experience with cloud/mobile application development and deployment (Android Studio, iOS) * Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS. * Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls). * Working knowledge of requirements lifecycle management tools (i.e. Helix ALM, Doors, Arena PLM) * Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market.
Physical Requirements (if applicable):
* Must be able to sit or stand for 8 hours a day
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