Staff Engineer, Systems
Danaher Corporation
Summary
The Staff Engineer, Systems is responsible for providing technical leadership in the design, development, integration, and validation of complex hardware and software systems for medical devices. This role leads system-level activities across user needs, architecture, requirements, risk management, usability, verification, validation, and regulatory compliance while providing technical direction and mentorship to cross-functional teams.
Job description
This position reports to the Director of Engineering and is part of the Engineering team located in Cincinnati, Ohio and will be an On-site role.
In this role, you will have the opportunity to:
- Lead the development and lifecycle management of 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, including resolution of complex cross-functional technical issues.
- Provide systems engineering leadership throughout product development, commercialization, design transfer, manufacturing readiness, regulatory submissions, audits, and lifecycle management.
- Mentor engineers and advance systems engineering tools, processes, and best practices while contributing to project planning, resource management, and technical decision-making.
The essential requirements of the job include:
- Bachelor's degree in engineering or a related field, such as systems, mechanical, or biomedical engineering.
- Minimum of 10 years of relevant engineering experience, including at least 5 years in systems engineering within the medical device industry.
- Demonstrated 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.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
- Ability to travel up to 15% of the time, including domestic and international travel and overnight, out-of-town assignments typically lasting 2 to 5 days.
- Ability to work in a typical office environment and occasionally visit laboratory, manufacturing, or clinical sites. Reasonable accommodations will be evaluated where needed.
It would be a plus if you also possess previous experience in:
- Master's degree in engineering or a related field.
- INCOSE Certified Systems Engineering Professional (CSEP), Project Management Professional (PMP), or a comparable relevant certification.
Requirements
- Bachelor's degree in engineering or a related field, such as systems, mechanical, or biomedical engineering.
- Minimum of 10 years of relevant engineering experience, including at least 5 years in systems engineering within the medical device industry.
- Demonstrated 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 travel up to 15% of the time, including domestic and international travel and overnight, out-of-town assignments typically lasting 2 to 5 days.
- Ability to work in a typical office environment and occasionally visit laboratory, manufacturing, or clinical sites.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401(k)
- Paid time off
- Bonus/incentive pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.