Senior Systems Engineer - Product Release (Medical Devices)

Location: Fridley, Minnesota, United States. This is an onsite office role. Candidates must have unrestricted U.S. work authorization at the time of hire and throughout employment. Sponsorship is not available for roles below Principal level.

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

Company

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

What you will do

• Lead system-level design, development, integration, and product release activities for implantable neuromodulation devices, instruments, and enabling technologies.
• 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 system verification and validation activities.
• Assess technical risks, hazards, and failure modes and support mitigation activities.
• Investigate field issues, change requests, and product performance data while collaborating with engineering, quality, regulatory, marketing, and project management 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; visa sponsorship is not available for this Senior-level role.

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.
• For degrees earned outside the United States, a qualifying degree under 8 C.F.R. § 214.2(h)(4)(iii)(A).

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Flexible Spending Account, life insurance, and disability coverage.
• Paid time off, paid holidays, tuition assistance, and employee assistance resources.
• 401(k) plan with employer contribution and match, incentive plans, and Employee Stock Purchase Plan.
• Global well-being program and additional retirement benefits subject to eligibility.