Staff Systems Engineer (Hybrid)

$109,316 - $163,975/Yr

Insulet Corporation - Acton, MA

Full-time - Mid Level

Hybrid - Acton, MA

Miscellaneous Manufacturing

About the position

The Staff Systems Engineer will serve as a technical lead in the design and development of Insulet's products, focusing on systems engineering activities within new product development projects. This role requires a comprehensive understanding of various engineering disciplines, including software, communications, electrical, mechanical, and materials, to ensure successful project deliverables and compliance with medical device regulations.

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 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 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)

Nice-to-haves

• 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

Benefits

• Competitive salary range of $109,316.00 - $163,974.50 based on role, level, and location
• Hybrid working arrangements with on-site work required at least once a week
• Equal opportunity employer with a commitment to diversity and inclusion
• Support for a healthy work-life balance
• Opportunities for professional development and training