Systems Engineer

Insulet Corporation•Acton, MA

4d•$81,700 - $122,500

About The Position

The Systems Engineer supports the R&D team and Insulet’s wearable pump technology innovation pipeline, with an emphasis on Lifecycle Engineering. The role provides broad exposure to the design, development, sustaining, and quality processes for wearable medical devices, including failure analysis, risk assessment, troubleshooting and design analysis, requirements interpretation and analysis, system integration, verification testing, and design documentation. The engineer supports product development and on-market product initiatives throughout the medical-device design and development lifecycle. Responsibilities include investigating field issues, evaluating risks and design changes, coordinating information between field-facing teams and development, conducting laboratory feasibility testing, and executing design verification testing for design improvements, regulatory clearances, or commercial release.

Requirements

Bachelor of Science in an engineering discipline, such as Biomedical Engineering or Computer Science.
At least 2 years of experience as a Systems Engineer or Project Engineer in the medical-device or another regulated industry, or equivalent experience.
Ability to work in a fast-paced, dynamic environment and a passion for continuous learning.
Passion for improving the lives of others.
Technical writing ability.
Experience with laboratory testing equipment.
Experience with Microsoft Office, including Word, Excel, and PowerPoint.
Effective communication skills.

Nice To Haves

Experience with Software as a Medical Device (SaMD).
Demonstrated working knowledge of engineering principles and scientific methods.
Strong systems-thinking and structured problem-solving skills.
Experience troubleshooting complex systems involving interacting hardware, software, mobile, cloud, connectivity, or third-party components.
Experience analyzing diagnostic logs, telemetry, system events, or large technical datasets.
Working knowledge of cloud systems, mobile technologies, APIs, wireless communications, and connected/IoT systems; described as a strong plus.
Experience with Amazon Web Services (AWS) or Microsoft Azure; described as a strong plus.
General understanding of medical-device risk and issue management; described as a strong plus.
Experience with software or product lifecycle tools such as Jira, Helix, Bamboo, Bitbucket, or Polarion; described as a strong plus.
Hands-on, inquisitive approach and willingness to challenge a design.
General understanding of medical devices and regulations.
Experience with data analysis tools such as MatLAB, Minitab, PowerBI, or similar.
Planning and organization skills.
Ability to organize and judge priorities in a dynamic environment.

Responsibilities

Collaborate with Systems Engineers to troubleshoot design issues and identify methods for improvement.
Work cross-functionally with teams including Customer Support, Product Support, Software Development, Product Management, and Quality.
Lead root-cause investigations, risk evaluations, and design-change assessments related to on-market product issues, supporting information transfer between field and development teams.
Own post-market initiatives, including field investigations and quality management processes.
Manage escalations and inquiries from field-facing partners about on-market products and report findings to internal issue-management teams when applicable.
Support all phases of the design and development lifecycle of a medical device.
Author engineering build requests and manage engineering materials.
Design and set up feasibility tests in a laboratory environment.
Author design feasibility protocols and reports.
Participate in product design, technical reviews, and triage brainstorming sessions.
Execute design verification testing in support of design improvements, FDA and international clearance, or commercial release.
Contribute to team goals by completing related tasks as required.