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.