Senior Systems Engineer (Only W2, No C2C, No Referral)

Title: Senior Systems Engineer (Only W2, No C2C, No Referral) - Onsite in MA/ CA

Duration: 6+ Months

Location: Acton, MA/ San Diego, CA

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

Minimum Requirements:

• 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.