Position Overview:
The Senior Systems Engineer will be a technical lead in the design and development of Insulet’s innovation pipeline of wearable medical devices, including cloud and data management systems. This position entails leading systems engineering activities within existing and new product development projects. Education and work experience should encompass a vast array of engineering disciplines to include software, electrical, mechanical, and materials.
Responsibilities:
• Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables.
• Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions.
• Contribute to system development by defining system and subsystem architectures .
• 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 technical consultant for integration, subsystem and system verification activities creating plans, protocols and reports, as necessary.
• Create and maintain traceability among design input, design output, design verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file.
• Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders.
• Serve as technical consultant for software development deliverables, such as design/architecture documents, requirements and failure mode analysis.
• Participate in Agile ceremonies, such as Program Increment (PI) Planning, Retrospectives, Inspect and Adapt.
• Provide guidance and support to junior engineers, promoting knowledge sharing and professional development
Education and Experience:
Minimum Requirements:
• Bachelor of Science or equivalent degree in an Engineering (Systems, Biomedical, Electrical, Computer Science) discipline or related engineering/technical degree is preferred.
• A minimum of 3 to 7+ years of experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment.
• 2+ years of experience in leading a cross-functional development team.
• Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments.
• Experience with long term R&D development programs (concept/feasibility, development, commercialization).
• Experience in application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors).
• Experience with root cause analysis and troubleshooting.
• Experience writing verification plans, protocols and reports in a regulated industry.
• Experience with data analysis (Minitab, JMP, or MatLAB).
• Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
• Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team, such as 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:
• Master of Science degree is desired; System Engineering training and/or certification is a plus
• Formal training in established Systems Engineering concepts.
• Experience in reliability engineering practices such as reliability/data-based performance modeling, performance testing, prediction, HALT and HASS.
• 1-2 years of experience working in Agile software development projects. Agile certification is a plus.
• 1-2 years of experience working with 3rd party partners/vendors.
• Domain expertise in one or more of the following: security, cloud, communication (BLE, NFC), circuit design.
• Six sigma training / certification.
• 2-3 years of experience in cloud technologies such as AWS and solid understanding of microservices, REST and HTTP
• General understanding of communication, mobile technology, IoT (Internet of Things), GDPR; a strong plus.
• Experience with SolidWorks or Pro-Engineer.
• Experience with change orders within a Product Lifecycle Management (PLM) tool (Arena PLM).
• Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market
• Experience with software tools and coding (C++, JAVA, Android UI).
Physical Requirements (if applicable):
• Must be able to sit or stand for 8 hours a day.
Additional Information:
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office). #LI-Hybrid
Additional Information:
Compensation & Benefits For U.S.-based positions only, the annual base salary range for this role is $99,825.00 - $149,737.50 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. 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.