Senior Systems Engineer (Medical Devices)

Location: Fridley, Minnesota, United States

Salary: $110,400–$165,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies, including implantable and enabling systems for neurological conditions.

What you will do

• Lead system-level design, development, integration, verification, and validation for neuromodulation products.
• Translate customer, clinical, and business needs into traceable stakeholder and system requirements.
• Define and manage system architectures, interfaces, workflows, use cases, and functional requirements across hardware and software.
• Plan, execute, analyze, and document verification and validation testing.
• Assess technical risks, hazards, and failure modes, and support mitigation activities.
• Investigate field issues and change requests, identify root causes, and implement engineering solutions with cross-functional teams.

Requirements

• Bachelor's degree with 4 years of relevant experience or master's degree with 2 years of relevant experience.
• Strong knowledge of Design Controls, requirements development, verification, validation, and lifecycle traceability.
• Experience working within a Quality Management System in a regulated environment.
• Experience collaborating with software, hardware, and multidisciplinary engineering teams.
• Experience in reliability engineering, verification and validation, or failure analysis.
• Unrestricted U.S. work authorization is required at hiring and throughout employment; sponsorship is not offered for roles below Principal level.

Nice to have

• Formal education, training, or hands-on experience in Systems Engineering methodologies.
• Medical device industry experience and familiarity with FDA, ISO 13485, or IEC 62304 requirements.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, short-term and long-term disability coverage, and life insurance.
• Health Savings Account, Flexible Spending Account, dependent daycare spending account, and tuition assistance.
• Incentive plans, Employee Stock Purchase Plan, Employee Assistance Program, and global well-being resources.