Principal Systems Engineer (Hybrid)

Position Overview
The Principal Systems Engineer is a senior individual contributor role within the Lifecycle Engineering team, responsible for driving technical excellence across a diverse range of initiatives. This role demands a high level of expertise in systems engineering fundamentals, regulatory compliance, and cross-functional collaboration. The successful candidate will be a hands-on problem solver, a strategic thinker, and a trusted technical advisor who can both dive deep into engineering challenges and provide actionable feedback across Insulet’s lifecycle engineering initiatives. This role is ideal for a versatile, self-motivated engineer with a broad technical foundation and the ability to adapt quickly across disciplines, projects, and challenges.

A core focus of this role is sustaining engineering—ensuring the continued safety, reliability, and compliance of products in the field. The Principal Systems Engineer will lead efforts in post-market surveillance, field issue resolution, and product improvements based on real-world performance data. This position offers the opportunity to influence product quality and performance throughout the lifecycle—from development and launch to sustaining and continuous improvement.

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 sustaining engineering activities for in-market products, including post-market surveillance, field issue resolution, and obsolescence planning.
• Drive root cause investigations and corrective actions for field issues, complaints, and adverse events.
• Monitor and analyze field performance data to identify trends and proactively mitigate risks.
• Lead design changes and updates to improve product reliability, manufacturability, and compliance.
• Collaborate with Quality and Regulatory teams to provide technical context on design and ensure timely and compliant resolution of CAPAs and audit findings.
• Lead and mentor systems engineers and promote best practices in systems engineering across the organization.
• 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.
• Lead the design, development, execution of novel test methods and risk management activities utilizing best engineering practices.
• Lead integration, subsystem and system verification activities creating plans, protocols and reports as necessary.
• Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders.

Education and Experience
• A Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Computer Science, Mechanical Engineering, or Biomedical Engineering is preferred.
• A minimum of 12 years of experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment.
• A minimum of 8 years of experience as a technical lead in cross-functional teams.
• Domain expertise in at least two disciplines; Mechanical, Electrical, Software.
• Experience with Requirement Management including Requirement Hierarchies, Traceability, Authorship, Platform vs Variant modalities.
• Experience with Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA).
• Experience with change management involving in-market products.
• 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/procurement/manufacturing/regulatory and quality experts.
• Experience with IEC 60601 family of standards, particularly in the context of electro-medical safety and performance.
• Hands-on experience with Bluetooth Low Energy (BLE) integration in medical or consumer devices.
• Proven experience with disposable product design, especially in high-volume manufacturing environments.

Preferred Skills and Qualifications
• Master of Science or equivalent degree in Systems Engineering, Electrical Engineering, Computer Science, Mechanical Engineering, or Biomedical Engineering is preferred.
• System Engineering training and/or certification is a preferred.
• Experience with continuous improvement methods and toolsets such as Six Sigma, Kaizen, CTQ and Critical Parameter Management. Six Sigma Green Belt or Black Belt certification is preferred.
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