Medical Device System Architect

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Date: Jun 7, 2024

Location:

Cincinnati, US

Job Type: Long-term/regular

Medical Device System Architect M/F (28756)

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.

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,

• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,

• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717