Senior Systems Engineer

Title: Sr Systems Engineer
Location: Must be local to Acton, MA or San Diego, CA
Duration: 06 Months with possible extension.

The Senior Systems Engineer will be a technical lead in the design and development of *’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.

• 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.

• Bachelor of Science in an Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical) discipline.
• 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.

• Master of Science degree is desired;
  Systems Engineering training and/or certification is a plus.
• Formal training in established Systems Engineering concepts.
• 1‑2 years of experience in Model‑based Systems Engineering.
• 1‑2 years of experience working in Agile software development projects. Agile certification is a plus.
• 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 in reliability engineering practices such as reliability/data‑based performance modeling, performance testing, prediction, HALT and HASS.
• 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 Solid Works or Pro‑Engineer.
• Experience with software tools and coding (C++, JAVA, Android UI).