Senior Systems Engineer (Remote/Flexible)

$101,970 - $152,955/Yr

Insulet Corporation

Full-time - Senior

Remote

Miscellaneous Manufacturing

About the position

The Senior Systems Engineer at Insulet will serve as a technical lead in the design and development of the company's innovative medical products. This role involves leading systems engineering activities within new product development projects, collaborating with cross-functional teams to ensure project deliverables are met while adhering to regulatory standards. The position emphasizes a multidisciplinary approach, requiring expertise in various engineering domains to enhance product functionality and safety.

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 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

• Remote working arrangements (100% remote or hybrid options available).
• Competitive salary range of $101,970.00 - $152,955.00 based on role, level, and location.