Systems Engineer

About this role

• Job Summary The Systems Engineer position is designed to provide the selected candidate with a broad exposure to the design, development, sustaining, and quality processes for wearable medical devices that are used by patients around the world daily.
• This position will be an integral member of the R&D team directly supporting the product development phases of Insulet's innovation pipeline of wearable pump technology, with an emphasis on technical support within Lifecycle Engineering.
• This role will provide exposure to several aspects of Insulet's design control and sustaining processes, including but not limited to failure analysis, risk assessment, troubleshooting / design analysis, interpreting and analyzing requirements, system integration, verification test methods, and design documentation.
• The Systems Engineer position is designed to provide the selected candidate with a broad exposure to the design, development, sustaining, and quality processes for wearable medical devices that are used by patients around the world daily.
• This position will be an integral member of the R&D team directly supporting the product development phases of Insulet's innovation pipeline of wearable pump technology, with an emphasis on technical support within Lifecycle Engineering.
• This role will provide exposure to several aspects of Insulet's design control and sustaining processes, including but not limited to failure analysis, risk assessment, troubleshooting / design analysis, interpreting and analyzing requirements, system integration, verification test methods, and design documentation.
• **Responsibilities** * Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement.
• * Collaborate cross-functionally including but not limited to Customer Support, Product Support, Software Development, Product Management, Quality organizations * Lead in root cause investigations, risk evaluations, and design change assessments related to on-market product issues; support seamless transition of information from the field to development and vice versa.
• * Own delivery of post-market initiatives, including field investigations and quality management processes.
• * Manage escalations and inquiries from field-facing partners related to on-market product, 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 with direct responsibility for managing engineering materials.
• * Design and set up feasibility tests in a lab environment.
• * Author design feasibility protocols and reports.
• * Participate in product design, technical reviews, and triage brainstorming sessions.
• * Design verification testing execution in support of design improvements, FDA and international clearance, or commercial release.
• Contribute to team goals by accomplishing related tasks as required **Basic Qualifications:** * BS in an Engineering (Biomedical, Computer Science) discipline * At least 2 years' experience as a Systems/Project Engineer in the Medical Device or other regulated industry and/or equivalent.
• * Ability to work in a fast paced, dynamic environment with a passion for continuous learning * Passionate about improving the lives of others * Technical writing ability * Experience with lab equipment (testing) * Microsoft office suite (Word, Excel, PowerPoint) Effective communication skills **Preferred Skills and Competencies:** * Experience with Software as a Medical Device (SaMD) preferred.
• * Demonstrated working knowledge of engineering principles and scientific methods.
• * Strong systems-thinking and structured problem-solving skills.
• * Experience troubleshooting complex systems consisting of interacting hardware, software, mobile, cloud, connectivity, and/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 (Internet of Things) systems; a strong plus.
• * Experience with Amazon Web Services (AWS), Microsoft Azure; a strong plus.
• * General understanding of medical device risk and issue management; a strong plus.
• * Experience with software / product lifecycle tools - Jira, Helix, Bamboo, Bitbucket, Polarion; a strong plus.
• * Hands-on and inquisitive, not being afraid to challenge a design.
• * General understanding of medical devices & regulations.
• * Experience with data analysis (MatLAB, Minitab, PowerBI, or similar analytical tools).
• * Planning and organization skills.
• Ability to organize and judge priorities in a dynamic environment.
• **Physical Requirements (if applicable):** Must be able to sit or stand for 8 hours a day Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $81,700.00 - $122,500.00 This position may also be eligible for incentive compensation.
• We offer a comprehensive benefits package, including: * Medical, dental, and vision insurance * 401(k) with company match * Paid time off (PTO) * And additional employee wellness programs Application Details: This job posting will remain open until the position is filled.
• To apply, please visit the Insulet Careers site and submit your application online.
• Actual pay depends on skills, experience, and education.
• 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.

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