Date:  Feb 12, 2024
Location: 

Cincinnati, US

Job Type:  Long-term/regular

  Senior Systems Engineer  M/F (28756)

 

The Senior Systems Engineer is responsible for the development and management of integrated requirements for medical devices in a cross functional team environment, and the development and management of the supporting programs, procedures, processes and tools.  This individual works to ensure that mechanical, electrical and software subsystems function reliably as an integrated system.

 

YOUR ROLE

- Lead the generation, review and release of integrated requirements package, including risk management principles and traceability that support the development and life cycle management of class II medical devices.

- Define system / subsystem architectures, by applying systems engineering processes. Specify module / component / user interfaces.

- Lead Risk Management activities (Risk analysis and FMEAs)

- Develop and maintain system architecture documentation, including the implementation of Functional Safety.

- Evaluate proposed changes to current products and perform root cause analyses to determine overall impact on the integrated system.

- Analyze the impact of evolutions of regulations and standards identified by regulatory team.

- Analyze patents and evaluate technical relevance to IP landscape for new products.

- Drive Variable Cost Productivity process at system level.

- Generate and manage models and prototypes to support analysis of the system, subsystem requirements, Design and solution.

- Develop and allocate usage models to support the system design life and reliability requirements and participate in the definition of associated reliability test plans.

- Work with other functional team members (i.e. software, electrical, mechanical, manufacturing, service, quality, etc.) to resolve system / interface issues by evaluating overall systems performance and function.

- Conduct technical reviews as defined in a structured, multi-stage, gated product development process.

- Participate in the development, review, and revision of procedures to support the use of systems engineering and risk management methodologies.

 

YOUR BACKGROUND

- Engineering degree​​​​​​ and 5+ years’ experience or more as a system engineer preferably in a regulated industry.

- Broad technical experience across disciplines including electrical, mechanical and software engineering.

- Experience in the development of processes and procedures which integrate systems engineering and risk management methods.

- Understanding of design control processes following ISO13485 or FDA 21 CFR 820 “Design Control Guidance for Medical Device Manufacturers”.

- Good knowledge of EN60601-1 standard and risk management techniques per ISO14971.

- Knowledge of software development standards IEC62304 is an asset, knowledge of functional safety per IEC61508.

- Understanding of requirements from Medical Devices Regulation for Class II medical devices.

- Proficient with the use and administration of requirements management tools, e.g. JAMA Connect

- Solid understanding of embedded software technology.

- Knowledge of usability engineering guidelines and processes per EN62366

- Demonstrated understanding of methods for modeling small to medium scale systems.

- Experience in medical device design required and in reliability design and test methods desirable.

- Strong analytical, problem solving skills, good interpersonal skills with ability to work with various business functions in an international environment.

- Good oral and written communication skills, especially technical writing in English.

- Self-starter and capable of working with minimal supervision.  Ability to multi-task across multiple projects.

- Six Sigma or DFSS experience preferred.

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


Nearest Major Market: Cincinnati