Systems Engineer

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,…