Senior System Engineer

Senior Systems Engineer

Pay: $83 to $84 an hour or about $171,000 a year

Location: Acton, MA 01720

Job Type: A Year Long Contract with opportunity to extend

The Senior Systems Engineer will serve as a technical lead in the design and development of Insulet’s innovative pipeline of wearable medical devices, including cloud-based and data management systems. This role leads systems engineering activities across both existing and new product development programs. The ideal candidate will have a broad engineering background spanning software, electrical, mechanical, and materials disciplines.

Key Responsibilities

• Serve as a core member of cross-functional project teams, collaborating with electrical, software, mechanical, manufacturing, and quality engineers to deliver project milestones.
• Lead system definition activities, including development of user needs, product requirements, and use-case descriptions.
• Define system and subsystem architectures to support system development.
• Identify, document, and manage system hazards, failure modes, and risk mitigations.
• Partner with technical centers of excellence, subject matter experts, and suppliers to assess, select, integrate, and qualify key components and subsystems.
• Act as a technical consultant for integration, subsystem, and system verification activities, including development of verification plans, protocols, and reports.
• Create and maintain full traceability between design inputs, design outputs, verification and validation activities, and risk management artifacts to ensure a complete and compliant Design History File (DHF).
• Support proposal development, project planning, effort estimation, and provide technical updates and status reports to leadership and key stakeholders.
• Serve as a technical consultant for software development deliverables, including design/architecture documentation, requirements, and failure mode analyses.
• Participate in Agile ceremonies such as Program Increment (PI) Planning, Retrospectives, and Inspect & Adapt sessions.
• Mentor and support junior engineers, fostering knowledge sharing and professional development.

Education and Experience

Minimum Qualifications

• Bachelor of Science in Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical, or related discipline).
• 3–7 years of experience working as a Systems Engineer or in a role with systems engineering responsibilities within multidisciplinary development teams.
• Minimum of 2 years of experience leading cross-functional development teams.
• Demonstrated expertise in systems engineering practices, including requirements management, design trade-off analysis, cost-benefit analysis, hazard identification, and risk assessment.
• Experience supporting long-term R&D development programs across concept/feasibility, development, and commercialization phases.
• Hands-on experience with Application Lifecycle Management (ALM) tools such as Polarion ALM, Helix ALM, or DOORS.
• Experience conducting root cause analysis and troubleshooting.
• Proven experience authoring verification plans, protocols, and reports in a regulated industry.
• Experience with data analysis tools such as Minitab, JMP, or MATLAB.
• Strong working knowledge of medical device regulations and standards, including ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820.30 (Design Controls).
• Demonstrated ability to work effectively within a Quality Management System (QMS) in cross-functional environments involving R&D, V&V, manufacturing, marketing, clinical, regulatory, and quality teams.
• Excellent written and verbal communication skills with the ability to engage at multiple organizational levels.
• Strong organizational skills with the ability to prioritize effectively in a dynamic environment.

Preferred Skills and Competencies

• Master of Science degree preferred; Systems Engineering training and/or certification is a plus.
• Formal training in established systems engineering methodologies.
• 1–2 years of experience in Model-Based Systems Engineering (MBSE).
• 1–2 years of experience working in Agile software development environments; Agile certification is a plus.
• Experience managing change orders within a Product Lifecycle Management (PLM) tool (e.g., Arena PLM).
• Demonstrated success developing innovative FDA-regulated medical devices, preferably within the drug delivery domain.
• Experience with reliability engineering practices, including data-driven modeling, performance testing, prediction, HALT, and HASS.
• 1–2 years of experience collaborating with third-party partners or vendors.
• Domain expertise in one or more of the following areas: cybersecurity, cloud technologies, wireless communication (BLE, NFC), or circuit design.
• Six Sigma training or certification.
• 2–3 years of experience with cloud technologies (e.g., AWS) and a solid understanding of microservices, REST APIs, and HTTP.
• General understanding of mobile technologies, IoT, communication protocols, and GDPR compliance.
• Experience with CAD tools such as SolidWorks or Pro/ENGINEER.
• Experience with software tools and coding languages including C , Java, and Android UI development.

Compensation Notes

• Target Pay Rate: $83–$84/hour