Systems Engineer (Remote/Flexible)

Position Overview:

The Systems Engineer 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. This role will provide exposure to several aspects of Insulet’s design control processes including but not limited to writing and interpreting product/software requirements, device integration, verification test methods, troubleshooting/design, risk analysis, and system architecture documentation. This position will report to Senior Manager, Systems Engineering.

Responsibilities:

• Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions
• Contribute to system development by defining system, subsystem architecture and design for manufacturing
• Identify and document system hazards, failure modes, and risk mitigations.
• Work with the technical centers of excellence domain subject matter experts, and suppliers in the assessment, selection, integration, and qualification of key components and subsystems
• Serve as a technical consulting resource for integration, subsystem and system verification activities creating plans, protocols and reports as necessary
• Oversee engineering evaluations & data analysis reviews
• Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts of the design in compliance with FDA guidelines
• Support the preparation of proposals, program plans, estimates, and present information and status to leadership and other stakeholders
• Drive product investigations, using statistical analysis methodologies
• Contribute to team goals by accomplishing related tasks as required

Education and Experience:

Minimum Requirements

• BS in Biomedical or Computer Science or any related engineering field
• A minimum of 3 years’ experience (inclusive of any post-grad work) working on technical design or Systems Engineering in a multidisciplinary project team environment
• 2+ years of experience in working on technical design
• Domain expertise in one of more associated domains; preferably Cloud or Data driven products, with exposure to Software, Quality, and Test Engineering
• Systems Engineering practices such as requirements management, risk analyses, design trade-off and cost-benefit analysis
• 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, manufacturing, marketing, clinical, regulatory and quality experts.
• Ability to communicate at multiple levels of an organization
• Ability to organize and judge priorities in a dynamic environment

Preferred Skills and Competencies:

• Experience or formal training in established Systems Engineering concepts
• Experience working on data driven products and/or medical data managements systems is a huge plus
• Experience working on integrations with Cloud based products and ETLs
• Experience with long term R&D development programs (concept/feasibility, development, commercialization)
• Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS.
• Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
• Working knowledge of requirements lifecycle management tools (i.e. Helix ALM, Doors, Arena PLM)
• Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market.
• Experience with root cause analysis
• Six sigma training / certification
• Experience with software tools and coding
• Experience with data analysis (Minitab, MatLAB)

Physical Requirements (if applicable):

• Must be able to sit or stand for 8 hours a day

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired).

Additional Information:

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.

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