Systems Engineer 4 (Medical Devices)

Location: Newark, Delaware, United States; onsite role

Annual base salary: $119,300–$186,600, plus bonus eligibility.

Company

hirify.global develops medical devices and related products designed for safe, effective, and compliant use in clinical practice.

What you will do

• Own system architecture and align product requirements, subsystem requirements, interfaces, and verification strategies.
• Lead requirement decomposition and allocation across software, hardware, electrical, mechanical, and clinical workflows.
• Direct system integration, technical trade-off analysis, verification, validation, and design transfer activities.
• Lead system-level risk management, including hazard analysis, FMEA, risk evaluation, and risk-control effectiveness assessments.
• Support regulatory submissions and maintain complete, traceable, audit-ready design-control documentation.
• Provide technical leadership across multiple programs, mentor engineers, and lead architecture, design, technical, and risk reviews.

Requirements

• College degree preferred; a master's degree is preferred for technical or advanced education.
• 8+ years of experience, or 6+ years with a master's degree or 3+ years with a PhD.
• Experience developing and sustaining complex medical systems combining mechanical, electrical, and software components in a regulated environment.
• Expert knowledge of systems engineering, requirements management, traceability, systems modeling, system integration, root-cause investigation, and problem resolution.
• Strong understanding of medical devices, FDA Quality System Regulations, ISO 13485, ISO 14971, IEC 60601, and basic IEC 62304 software lifecycle requirements.
• Strong leadership, communication, negotiation, stakeholder-management, and cross-functional coordination skills; ability to manage multiple large-scale projects.

Nice to have

• Experience with Agile and Oracle.
• Ability to develop and deliver high-quality presentations.

Culture & Benefits

• Comprehensive onboarding, continued professional development, and career training.
• Competitive annual salary and bonus scheme.
• Less than 10% travel.
• Work includes collaboration with Design Assurance, Regulatory Affairs, Clinical Affairs, Clinical Applications, Marketing, and Customer Experience.