At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Join the Surgical OU systems engineering team working on a new endoluminal surgical robotic platform! Bring your medical device software background and experience to a new robotic platform that combines surgical robotic arms, AI compute and connectivity hub, electromagnetic navigation guidance, disposable articulating catheters, camera & illumination technology, and cloud based surgical solutions. This role will be responsible for partnering with teams across the OU to define, integrate, and validate of the system level software and software sub-systems for the SC ELR (Single Channel Endoluminal Robotics project with an initial application for lung cancer diagnosis. This includes ensuring an aligned set of software solutions to meet or exceed customer expectation.

Medtronic is looking for a Senior Principal Systems Engineer. This role will collaborate across the Surgical OU Research and Development organization to bring innovation to patients. The successful candidate will be accountable for the definition, integration, and validation of system solutions to meet the ever-evolving needs of our patients, physician partners, and our business. She or he will be accountable for systems design control deliverables and exert significant influence over the design solution. She or he will lead a cross functional team to perform needs analysis, use case analyses, functional analyses, requirements development, and system and subsystem architecture documentation. She or he will also coordinate and lead trade-off studies, prototype evaluations, and clinical acceptability studies.  

  

You will: 

• Report to a Systems Engineer Manager within the Systems Center of Excellence of the Surgical Operating Unit 
• Actively participate in regular R&D project team meetings for the development of new complex surgical systems 
• Lead a group of systems engineers in the development and timely delivery of systems design control deliverables 
• Contribute to planning and execution of pre-clinical laboratory studies to evaluate the acceptability of product prototypes 
• Apply Systems Engineering principles and best practices to new product development 
• Actively contribute to risk management including hazard analysis, usability risk analysis, and risk mitigation 
• Communicate progress and roadblocks to project management organization and technical leadership 
• Direct the day-to-day activities of, and mentorship to junior systems engineers 
• Provide post commercialization product support including root cause investigation and resolution activities 

Must Have: Minimum Requirements: 

• Bachelor’s degree in Biomedical, Electrical, Mechanical, or Systems Engineering required 
• Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience 
• Fluency in English and authorization to work in the US is required 

Nice to have: 

• Mastery of Systems Engineering principles and practices 
• Track record of working independently and setting priorities to implement strategic goals 
• Demonstrated expertise in the definition, development, and integration of complex, software enabled medical device systems 
• Advanced knowledge of product security across the complete lifecycle of the system 
• Robust ability to effectively communicate complicated information with internal, external, and non-technical audiences 
• Excellent understanding of design controls and good documentation practices 
• Advanced knowledge of standards including IEC 60601, ISO 14971, ISO 13485 and 62366 
• Experience with IEC 2800-1 and FDA Medical Device Interoperability guidance 
• Advanced degree in Biomedical, Electrical, Mechanical, or Systems Engineering 
• Experience with medical robotics and combination capital-disposable equipment 
• Experience with web-connected medical devices 
• History of negotiating with internal and external groups to reach common understanding and achieve shared goals 
• Demonstrated ability to strongly influence the design of new products and direct team activities without direct authority 
• Advanced knowledge of requirements management, risk management, and system architecture development 
• Proficiency in hardware, software, and electrical engineering practices and product development 
• Practical experience utilizing Model Based Systems Engineering in product development 
• Proven track record of developing complex products in