Systems Engineer

Insulet Corporation•Acton, MA

About The Position

The Systems Engineer supports the design, development, sustaining, and quality processes for wearable medical devices. As a member of the R&D team, the role supports product development across Insulet’s wearable pump technology innovation pipeline, with an emphasis on technical support within Lifecycle Engineering. The position provides exposure to design control and sustaining processes, including failure analysis, risk assessment, troubleshooting and design analysis, requirements interpretation and analysis, system integration, verification test methods, and design documentation.

Requirements

Bachelor of Science degree 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.
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.
Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
Effective communication skills.
Demonstrated working knowledge of engineering principles and scientific methods.
Strong systems-thinking and structured problem-solving skills.
Hands-on, inquisitive approach and willingness to challenge a design.
General understanding of medical devices and regulations.
Planning and organizational skills, including the ability to organize and judge priorities in a dynamic environment.
Ability to sit or stand for 8 hours a day.

Nice To Haves

Experience with Software as a Medical Device (SaMD).
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.
Experience with Amazon Web Services (AWS) or Microsoft Azure.
General understanding of medical device risk and issue management.
Experience with software or product lifecycle tools such as Jira, Helix, Bamboo, Bitbucket, or Polarion.
Experience with data analysis tools such as MatLAB, Minitab, or PowerBI.

Responsibilities

Collaborate with experienced Systems Engineers to troubleshoot design issues and identify methods for improvement.
Collaborate cross-functionally with groups 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 the field and development teams.
Own delivery of post-market initiatives, including field investigations and quality management processes.
Manage escalations and inquiries from field-facing partners about on-market products, reporting 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, regulatory clearances, or commercial release.
Contribute to team goals by completing related tasks as required.