Hybrid Systems Engineer

at Diabetes Youth Families

• Job title: Systems Engineer
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $79,650 - $119,475 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Acton, United States

About the role

• Systems Engineer developing product requirements and system architecture for insulin management technology. Collaborating with R&D team and ensuring compliance with FDA guidelines.

Responsibilities

• Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions.
• Contribute to system development by defining system, subsystem architecture and design for manufacturing.
• 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 a technical consulting resource for integration, subsystem and system verification activities creating plans, protocols and reports as necessary.
• Oversee engineering evaluations & data analysis reviews.
• Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts of the design in compliance with FDA guidelines.
• Support the preparation of proposals, program plans, estimates, and present information and status to leadership and other stakeholders.
• Drive product investigations, using statistical analysis methodologies.
• Contribute to team goals by accomplishing related tasks as required.

Requirements

• Bachelor's Degree required (preferred field of study in Engineering including Biomedical, Electrical, Software, Mechanical)
• A minimum of three (3) years’ experience (inclusive of any post-grad work) working on technical design or Systems Engineering in a multidisciplinary project team environment.
• 2+ years of experience in working on technical design.
• Domain expertise in one of more associated domains; preferably Electrical or Mechanical Engineering, with exposure to Software, Quality, and Test Engineering.
• Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes 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.

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs