Staff Engineer, Systems (Medical Devices)

Location: On-site in Cincinnati, Ohio, United States. Travel of up to 15% may be required, including domestic and international overnight assignments lasting 2 to 5 days.

Annual salary: $130,000–$155,000, plus eligibility for bonus or incentive pay.

Company

hirify.global is a life sciences, diagnostics, and biotechnology company operating through businesses including Mammotome, a medical device company focused on breast care and cancer diagnostics.

What you will do

• Lead user needs, system requirements, traceability, and change control for complex medical device projects.
• Translate customer, clinical, business, and regulatory inputs into system architectures, technical requirements, integration plans, and verification strategies.
• Lead system-level design, product risk management, usability engineering, verification, and validation activities.
• Resolve complex cross-functional technical issues and provide systems engineering leadership throughout product development, commercialization, design transfer, manufacturing readiness, regulatory submissions, audits, and lifecycle management.
• Mentor engineers and improve systems engineering tools, processes, and best practices while contributing to project planning, resource management, and technical decisions.

Requirements

• Bachelor’s degree in engineering or a related field such as systems, mechanical, or biomedical engineering.
• At least 10 years of relevant engineering experience, including at least 5 years in systems engineering within the medical device industry.
• Experience with requirements management, system architecture, risk analysis, usability engineering, and system verification and validation.
• Experience translating customer, clinical, business, and regulatory inputs into system-level requirements, architectures, and verification strategies.
• Experience providing technical direction to cross-functional teams and resolving complex system-level issues.
• Ability to work on-site in Cincinnati and occasionally visit laboratory, manufacturing, or clinical sites.

Nice to have

• Master’s degree in engineering or a related field.
• INCOSE Certified Systems Engineering Professional, Project Management Professional, or comparable certification.

Culture & Benefits

• Work within a cross-functional engineering team focused on improving medical device outcomes in breast care.
• Paid time off and medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Opportunity to contribute to hirify.global’s continuous improvement system and technical best practices.