Insulet Corporation · 4 months ago
Principal Systems Engineer (Hybrid)
US - California
Full-time
Hybrid
Senior Level, Lead/Staff
$150K/yr - $225K/yr
12+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. They are seeking a Principal Systems Engineer to drive technical excellence and lead sustaining engineering efforts to ensure product safety and compliance throughout the lifecycle.
Health CareMedicalMedical Device
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
Qualification
Required
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
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
Experience with advanced root cause analysis methods such as Statistical Analysis, Cause and Effect, A3, 5 Whys and 8Ds is preferred
Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS is preferred
Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market is preferred
Experience using Minitab, ReliaSoft or similar tools preferred
Familiarity with lifecycle tools (e.g., Polarion ALM, Helix ALM) preferred
Company
Insulet Corporation
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase