Staff Engineer, Systems

Danaher seeks a Staff Engineer, Systems to lead technical design and development of complex medical device systems at Mammotome in Cincinnati. The role encompasses systems architecture, requirements management, risk assessment, and cross-functional team leadership throughout product lifecycle and regulatory compliance.

Responsibilities

• Lead development and lifecycle management of user needs, requirements, traceability, and change control for medical device projects
• Translate customer and regulatory inputs into system architectures, technical requirements, and verification strategies
• Direct system-level design, risk management, usability engineering, and validation activities
• Provide systems engineering leadership from product development through commercialization, regulatory submission, and lifecycle management
• Mentor engineers and advance systems engineering tools, processes, and best practices

Requirements

• Bachelor's degree in engineering, systems, mechanical, or biomedical engineering
• Minimum 10 years relevant engineering experience; at least 5 years in medical device systems engineering
• Demonstrated expertise in requirements management, system architecture, risk analysis, and verification/validation
• Experience translating clinical, regulatory, and business inputs into system-level requirements and architectures
• Proven ability to provide technical direction and resolve complex cross-functional technical issues

Compensation: $130,000-$155,000 base, plus eligible bonus/incentive pay