About the role

Principal Systems Engineer driving technical excellence within Lifecycle Engineering at Insulet Corporation. Leading cross-functional teams in product reliability and compliance efforts for medical devices.

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.

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.