Senior System Engineer

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.

• 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.

• 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.

• Master of Science degree preferred;
  Systems Engineering training and/or certification is a plus.
• 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…