PURPOSE AND SCOPE:
The Sr. Engineer possesses specific product lines knowledge to be a resource and key technical expert to support related projects. The Sr. Engineer is largely unsupervised and self-motivated to lead projects. Shall be capable of being given high level tasks and working independently to organize work, from required Cross Functional Teams (CFT) and to produce the final product or outcome assigned. The Sr. Engineer is expected to be trusted to provide production support to ensure product reliability, dependability and efficient manufacturability. The Sr. Engineer is also capable of formulating new research projects - from starting with a concept, formulating a pre-development plan and completing a feasibility study. The Sr. Engineer can act as the expert in a cross technical team (CTT) to execute a project and/or solve hard to diagnose problems. The Sr. Engineer, as a technical expert, may be called upon to provide system related technical seminars across the company.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Establishes and maintains product requirements and interface design definition by collaborating with cross-functional disciplines within the product development environment.
Conducts product safety analysis and develop design solutions to mitigate risks. Utilizes risk analysis to enhance safety and design robustness.
Provides technical guidance and support external and internal customers throughout the product life cycle. Conduct feasibility of potential technical solutions and allocation of derived requirements onto affected subsystem.
Specifies and develops improvements or enhancements to existing products and champion implementation if necessary.
Develops the planning, organization, implementation, and monitoring of system engineering processes, tools, risk and issue tracking.
Contributes to development of design verification and design validation protocols.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Supervises and coordinates external service providers
Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Windchill and Polarion key user
Networks with senior internal and external personnel in own area of expertise.
Normally receives little instruction on day-to-day work, general instructions on new assignments.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EXPERIENCE AND REQUIRED SKILLS:
Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree desirable
5 - 8 years' related experience
Experience in developing customer and product requirements, translating requirements into systems level architecture designs and interface design definitions, and requirement allocation.
Strong hands-on skills in complex system design, integration, testing, and troubleshooting. Familiar with quality management system, product safety analysis, risk assessment and mitigation, and dFMEA/ pFMEA/Use-MisUse FMEA/FTA.
Experience in medical device development.
Strong preference for experience with requirements management, modeling and issue/defect tracking tools e.g. Polarion, Cognition Cockpit, Jira, Windchill, SysML, MagicDraw etc.
Excellent oral and written communication skills with ability to interact directly with cross-functional team members, and external partners.
Excellent analytical and problem solving skills in mechanical and electrical systems.
Strong preference for experience with FDA design controls and ISO 14971 risk management.
Experience with modeling and simulation tools such as MATLAB, Labview, or Simulink preferred.
Dialysis products experience preferred
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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