{"schemaVersion":"jobsearcher.job.v1","id":"92171b07fe4cb42d6e07d4f9","url":"https://jobsearcher.com/jobs/92171b07fe4cb42d6e07d4f9","canonicalUrl":"https://jobsearcher.com/jobs/92171b07fe4cb42d6e07d4f9","title":"Senior System Engineer","description":"Location: Acton, MA 01720\n\nJob Type: A Year Long Contract with opportunity to extend\n\nThe 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.\n\nKey Responsibilities\n\nServe as a core member of cross‑functional project teams, collaborating with electrical, software, mechanical, manufacturing, and quality engineers to deliver project milestones.\n\nLead system definition activities, including development of user needs, product requirements, and use‑case descriptions.\n\nDefine system and subsystem architectures to support system development.\n\nIdentify, document, and manage system hazards, failure modes, and risk mitigations.\n\nPartner with technical centers of excellence, subject matter experts, and suppliers to assess, select, integrate, and qualify key components and subsystems.\n\nAct as a technical consultant for integration, subsystem, and system verification activities, including development of verification plans, protocols, and reports.\n\nCreate 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).\n\nSupport proposal development, project planning, effort estimation, and provide technical updates and status reports to leadership and key stakeholders.\n\nServe as a technical consultant for software development deliverables, including design/architecture documentation, requirements, and failure mode analyses.\n\nParticipate in Agile ceremonies such as Program Increment (PI) Planning, Retrospectives, and Inspect & Adapt sessions.\n\nMentor and support junior engineers, fostering knowledge sharing and professional development.\n\nMinimum Qualifications\n\nBachelor of Science in Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical, or related discipline).\n\n3–7+ years of experience working as a Systems Engineer or in a role with systems engineering responsibilities within multidisciplinary development teams.\n\nMinimum of 2 years of experience leading cross‑functional development teams.\n\nDemonstrated expertise in systems engineering practices, including requirements management, design trade‑off analysis, cost‑benefit analysis, hazard identification, and risk assessment.\n\nExperience supporting long‑term R&D development programs across concept/feasibility, development, and commercialization phases.\n\nHands‑on experience with Application Lifecycle Management (ALM) tools such as Polarion ALM, Helix ALM, or DOORS.\n\nExperience conducting root cause analysis and troubleshooting.\n\nProven experience authoring verification plans, protocols, and reports in a regulated industry.\n\nExperience with data analysis tools such as Minitab, JMP, or MATLAB.\n\nStrong working knowledge of medical device regulations and standards, including ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820.30 (Design Controls).\n\nDemonstrated 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.\n\nExcellent written and verbal communication skills with the ability to engage at multiple organizational levels.\n\nStrong organizational skills with the ability to prioritize effectively in a dynamic environment.\n\nPreferred Skills and Competencies\n\nMaster of Science degree preferred; Systems Engineering training and/or certification is a plus.\n\n1–2 years of experience in Model‑Based Systems Engineering (MBSE).\n\n1–2 years of experience working in Agile software development environments; Agile certification is a plus.\n\nExperience managing change orders within a Product Lifecycle Management (PLM) tool (e.g., Arena PLM).\n\nDemonstrated success developing innovative FDA‑regulated medical devices, preferably within the drug delivery domain.\n\nExperience with reliability engineering practices, including data‑driven modeling, performance testing, prediction, HALT, and HASS.\n\n1–2 years of experience collaborating with third‑party partners or vendors.\n\nDomain expertise in one or more of the following areas: cybersecurity, cloud technologies, wireless communication (BLE, NFC), or circuit design.\n\nSix Sigma training or certification.\n\n2–3 years of experience with cloud technologies (e.g., AWS) and a solid understanding of microservices, REST APIs, and HTTP.\n\nGeneral understanding of mobile technologies, IoT, communication protocols, and GDPR compliance.\n\nExperience with CAD tools such as SolidWorks or Pro/ENGINEER.\n\nExperience with software tools and coding languages including C++, Java, and Android UI development.\n\nCompensation Notes\n\nTarget Pay Rate: $83–$84/hour\n\n#J-18808-Ljbffr","company":"Advantage Technical","rawCompany":"advantage technical","city":"Acton","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-07-16T03:59:46.569Z","occupations":[{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior System Engineer","description":"Location: Acton, MA 01720\n\nJob Type: A Year Long Contract with opportunity to extend\n\nThe 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.\n\nKey Responsibilities\n\nServe as a core member of cross‑functional project teams, collaborating with electrical, software, mechanical, manufacturing, and quality engineers to deliver project milestones.\n\nLead system definition activities, including development of user needs, product requirements, and use‑case descriptions.\n\nDefine system and subsystem architectures to support system development.\n\nIdentify, document, and manage system hazards, failure modes, and risk mitigations.\n\nPartner with technical centers of excellence, subject matter experts, and suppliers to assess, select, integrate, and qualify key components and subsystems.\n\nAct as a technical consultant for integration, subsystem, and system verification activities, including development of verification plans, protocols, and reports.\n\nCreate 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).\n\nSupport proposal development, project planning, effort estimation, and provide technical updates and status reports to leadership and key stakeholders.\n\nServe as a technical consultant for software development deliverables, including design/architecture documentation, requirements, and failure mode analyses.\n\nParticipate in Agile ceremonies such as Program Increment (PI) Planning, Retrospectives, and Inspect & Adapt sessions.\n\nMentor and support junior engineers, fostering knowledge sharing and professional development.\n\nMinimum Qualifications\n\nBachelor of Science in Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical, or related discipline).\n\n3–7+ years of experience working as a Systems Engineer or in a role with systems engineering responsibilities within multidisciplinary development teams.\n\nMinimum of 2 years of experience leading cross‑functional development teams.\n\nDemonstrated expertise in systems engineering practices, including requirements management, design trade‑off analysis, cost‑benefit analysis, hazard identification, and risk assessment.\n\nExperience supporting long‑term R&D development programs across concept/feasibility, development, and commercialization phases.\n\nHands‑on experience with Application Lifecycle Management (ALM) tools such as Polarion ALM, Helix ALM, or DOORS.\n\nExperience conducting root cause analysis and troubleshooting.\n\nProven experience authoring verification plans, protocols, and reports in a regulated industry.\n\nExperience with data analysis tools such as Minitab, JMP, or MATLAB.\n\nStrong working knowledge of medical device regulations and standards, including ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820.30 (Design Controls).\n\nDemonstrated 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.\n\nExcellent written and verbal communication skills with the ability to engage at multiple organizational levels.\n\nStrong organizational skills with the ability to prioritize effectively in a dynamic environment.\n\nPreferred Skills and Competencies\n\nMaster of Science degree preferred; Systems Engineering training and/or certification is a plus.\n\n1–2 years of experience in Model‑Based Systems Engineering (MBSE).\n\n1–2 years of experience working in Agile software development environments; Agile certification is a plus.\n\nExperience managing change orders within a Product Lifecycle Management (PLM) tool (e.g., Arena PLM).\n\nDemonstrated success developing innovative FDA‑regulated medical devices, preferably within the drug delivery domain.\n\nExperience with reliability engineering practices, including data‑driven modeling, performance testing, prediction, HALT, and HASS.\n\n1–2 years of experience collaborating with third‑party partners or vendors.\n\nDomain expertise in one or more of the following areas: cybersecurity, cloud technologies, wireless communication (BLE, NFC), or circuit design.\n\nSix Sigma training or certification.\n\n2–3 years of experience with cloud technologies (e.g., AWS) and a solid understanding of microservices, REST APIs, and HTTP.\n\nGeneral understanding of mobile technologies, IoT, communication protocols, and GDPR compliance.\n\nExperience with CAD tools such as SolidWorks or Pro/ENGINEER.\n\nExperience with software tools and coding languages including C++, Java, and Android UI development.\n\nCompensation Notes\n\nTarget Pay Rate: $83–$84/hour\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T03:59:46.569Z","dateModified":"2026-07-16T03:59:46.569Z","hiringOrganization":{"@type":"Organization","name":"Advantage Technical","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Acton","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"92171b07fe4cb42d6e07d4f9"},"url":"https://jobsearcher.com/jobs/92171b07fe4cb42d6e07d4f9"}}