WHAT WE’RE LOOKING FOR:

We are seeking a dynamic Sr. Systems Architect to lead the development and oversight of integrated requirements for medical devices within a collaborative, cross-functional team environment. This role involves managing programs, procedures, processes, and tools to ensure seamless operation of mechanical, electrical, and software subsystems as a cohesive and reliable integrated system. This position is based at our Cincinnati, Ohio site.

YOUR ROLE:

• Develop and maintain system architecture documentation with a focus on implementing functional safety.
• Evaluate proposed changes to existing products and conduct root cause analyses to assess their impact on the integrated system.
• Analyze the effects of evolving regulations and standards identified by the regulatory team.
• Assess patents and determine their technical relevance to the IP landscape for new products.
• Drive the Variable Cost Productivity process at the system level.
• Generate and manage models and prototypes to support system and subsystem requirements analysis, design, and solution.
• Allocate usage models to ensure system design life and reliability requirements are met and participate in defining associated reliability test plans.
• Collaborate with other functional team members to resolve system and interface issues by evaluating overall systems performance and function.
• Conduct technical reviews as part of a structured, multi-stage, gated product development process.
• Contribute to the development, review, and revision of procedures that support the use of systems engineering and risk management methodologies.

YOUR BACKGROUND:

Education:

• Engineering degree

Experience:

• 5 years of experience as a systems engineer, preferably in a regulated industry.
• Experience in medical device design is required.

Skills/Competencies:

• 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.
• Test methods and reliability design are preferred.
• Understands the requirements outlined by the Medical Devices Regulation for Class II medical devices.
• Can use and administer requirements management tools such as JAMA Connect.
• Familiar with usability engineering guidelines and processes per EN62366.

• 4 weeks PTO
• Medical, Dental, Vision benefits start on date of hire
• Competitive 4% 401k mathc 2% profit sharing contribution
• Tuition reimbursement