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Sr. Engineer, Systems (Reliability)

Company: Fresenius Medical Care
Location: Lawrence
Posted on: June 6, 2021

Job Description:

Global Research & Development

Our Global Commitment to Deliver

Around 3 million individuals worldwide suffer from renal failure. With innovative products and therapies we define highest standards for the dialysis treatment of patients with chronic kidney failure and extracorporeal therapies for organ support.

Our Global Research & Development (GRD) activities enable us to develop products efficiently and to systematically promote the exchange of knowledge and technology between regions. Our intention to develop innovative products that are not only of the highest quality, but are also affordable so that caregivers and patients can benefit from them.

Click to Learn more about the Global Research and Development Organization!

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:

  • Provide system engineering subject matter expertise to support medical product development.
  • Work on complex problems where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Develop technical solutions for complex problems that require the regular use of ingenuity and creativity.
  • Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining solutions.
  • Establish product requirements and interface design definition by collaborating with cross-functional disciplines within the product development environment.
  • Conduct product safety analysis and develop design solutions to mitigate risks. Utilizes risk analysis to enhance safety and design robustness.
  • Provide 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.
  • Specify and develop improvements or enhancements to existing products and champion implementation if necessary.
  • Develop the planning, organization, implementation, and monitoring of requirement management processes, tools, risk, and issue tracking.
  • Develop & execute system verification and validation plans, protocols and reports for multiple projects by analyzing system requirements.
  • Apply concepts of FDA design controls, risk management, and process validation (IQ/OQ/PQ)
  • Work with product development teams to evaluate system interfaces, operational requirements, and performance requirements.
  • Create, identify, validate, and use test tools that facilitate data gathering and test method execution.
  • Participate in the design, build, validation and deployment of effective test automation solutions.
  • Understand defect management and works on defect resolution.
  • Maintain effective communication with the project manager and team members on project scope, timelines, and design changes.
  • Contribute at a high level on cross-functional teams within the organization.
  • Plan and execute reliability projects.
  • Develop product reliability and availability goals and requirements.
  • Support product functional modeling and allocate reliability and/or availability to lower levels.
  • Lead reliability and availability prediction efforts.
  • Facilitate FMEA and FTA.
  • Develop test methods procedures for estimating or demonstrating required levels of product reliability.
  • Implement HALT, HAST, HASS, HASA and ALT and other appropriate testing protocols.
  • Review product reliability targets and test results to confirm reliability.
  • Perform data analytics such as Reliability level, Weibull, Growth Analysis, MTBF/MTTR.
  • 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.

EDUCATION:

  • Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS:

  • 5 - 8 years' related experience;Master's degree with >3 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 product safety analysis, risk assessment, mitigation, and dFMEA/ pFMEA / FTA.
  • Familiar with requirements management, modeling and issue/defect tracking tools e.g. DOORS, Cognition Cockpit, Jira, TFS, 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. Hydraulics experience preferred.
  • 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.
  • Strong understanding of product development process related to medical devices.
  • Knowledge of regulatory (FDA) and applicable standards ISO 13485, ISO 14971 is desirable.
  • Experience in investigational analysis methods such as root cause analysis and design of experiments a plus.
  • Ability to interface cross functionally.
  • Strong interpersonal skills with a team focus.
  • Proactive and self-directed.
  • Ability to be productive and stay focused on deliverables in a fast-paced working environment.
  • Experience in medical device development desired
  • Experience and certification in Design for Six Sigma and Design for Reliability strongly 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.

Keywords: Fresenius Medical Care, Lawrence , Sr. Engineer, Systems (Reliability), Other , Lawrence, Massachusetts

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