Principal Systems Engineer (hybrid)

Principal Systems Engineer

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.

• 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.

Work Environment

• Hybrid work arrangement; requires on-site presence at least three (3) days per week.

• Must be able to sit or stand for up to 8 hours per day.

Additional Information:

The US base salary range for this full-time position is $149,700.00 - $224,550.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

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. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.