WHAT WE'RE LOOKING FOR:

The Medical Device System Architect oversees the creation and oversight of integrated requirements for medical devices within a cross-functional team environment. Additionally, they are responsible for developing and managing the supporting programs, procedures, processes, and tools. Their primary goal is to ensure that the mechanical, electrical, and software subsystems operate seamlessly as a cohesive and dependable integrated system. This position is located at our Cincinnati, Ohio site.

YOUR ROLE:

• Developing and maintaining system architecture documentation, with a focus on implementing functional safety. 
• Evaluating proposed changes to existing products and conducting root cause analyses to assess their impact on the integrated system.
• Analyzing the effects of evolving regulations and standards identified by the regulatory team. 
• Assessing patents and determining their technical relevance to the IP landscape for new products.
• Driving the  Variable Cost Productivity process at the system level.
• Generating and managing models and prototypes to support system and subsystem requirements analysis, design and solution.
• Allocating usage models to ensure system design life and reliability requirements are met and participating in defining associated reliabilty test plans.
• Collaborating with other functional team members to resolve system and interface issues by evaluating overall systems performance and function.
• Conducting technical revuews as part of a structured, multi-stage, gated product development process.

• Contributing to the development, review and revision of procedures that support the use of systems engineering and risk management methodologies.

   

YOUR BACKGROUND:

• Engineering degree
• 5+ years of experience as a systems engineer, preferrably in a regulated industry.
• Demonstrates broad technical expertise across disciplines including electrical, mechanical and software engineering.
• Familiar with design control processes following ISO13485 or FDA 21 CFR 820 guidelines for medical device manufacturers.
• Proficient in EN60601-1 standard and skilled in risk management techniques per ISO14971.
• Six Sigma or DFSS experience is preferred
• Experience in medical device design is required 
• Test methods and  reliability design are preferred 9. Understands the requirements outlined by the Medical Devices Regulation for Class II medical devices
• Can use and administer requirements managements tools such as JAMA Connect.

• Familiar with usability engineering guidelines and processes per EN62366.