Sr. Engineer, Systems (Reliability)
Company: Fresenius Medical Care
Posted on: June 6, 2021
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
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
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
- 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
- Develop & execute system verification and validation plans,
protocols and reports for multiple projects by analyzing system
- 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
- 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
- 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
- Plan and execute reliability projects.
- Develop product reliability and availability goals and
- 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
- Review product reliability targets and test results to confirm
- 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.
- 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
- 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
- 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
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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