Staff Engineer, Systems

Staff Engineer, SystemsBring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Mammotome, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.At Mammotome, our expertise and compassion for breast care makes us the indispensable partner to physicians, clinicians and patients. Our drive for developing innovative technology is rivaled only by our compassion for the people we serve, from the clinicians and surgeons who demand consistently precise solutions, to the patients and families seeking peace of mind. When you join our company, you join in the fight against breast cancer. Working at Mammotome means you will have the opportunity to collaborate with a diverse, hardworking, high-performing team committed to improving patient outcomes. As a trusted leader in breast cancer diagnostics, we invite you to join us and support products you can feel passionate about!Learn about the Danaher Business System which makes everything possible.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.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.Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.