Sr. Systems Engineer - NxStage - Fresenius Medical Care Holdings, Inc.

Position Summary:  

We are seeking an experienced and creative hands-on Senior Systems Engineer who will effectively work in cross-functional engineering teams. You will play a key role in the design, development, testing, and documentation of next generation dialysis instruments at NxStage Medical. The incumbent will support and/or lead systems engineering related activities on product development programs. You will need necessary experience/skills to work with software, hardware and systems integration teams to implement efficient solutions to address complex analytical/hardware issues. This role will require strong engineering, analytical, troubleshooting and testing skills. You will support the capture and tracking of technical risk parameters, design risks, and track to risk management strategies.

Key Responsibilities: 

• Provide technical leadership role in a cross-functional product development environment.
• Model and analyze complex electro/mechanical medical devices.
• Provide hands-on support for various engineering aspects of the project, perform feasibility studies for proposed design, systems or processes and prepare technical presentations to development team.
• Lead proof-of-concept and feasibility efforts from a system perspective, driving studies and experiments.
• Compile technical data for Design History Files per FDA requirements. 
• Participates in Cross-Functional Teams in efforts relating to system requirements definition, system functional decomposition and requirements allocation, system architecture definition, system modeling, and requirements traceability and compliance including verification plans and reports.
• Perform Risk Analyses, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities.
• Draft work instructions (WI), SOPs, engineering reports, drawings and necessary documentation in order to release design changes.
• Designs, defines, implements and / or tests complex system requirements; develops integrated solutions in consideration of scientific, engineering, manufacturing and service disciplines.
• Analyze complex, multi-disciplinary technical issues encountered during the operation and use of instruments.  Develop, test, recommend and implement corrective actions to address these issues.

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:        

• 7+ years experience working as a Systems Engineer in Medical Device Industry.

Requirements: 

• Strong understanding of medical device product design and regulatory processes.
• Able to communicate effectively, both verbally and in writing.
• Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
• Strong understanding of system design, electronics, mechanical and software integration.
• Knowledge of design of experiments.
• Technical understanding of and experience with best-practice product development methodologies.
• Experience with model bases systems engineering and life cycle management tools such as Enterprise Architect.
• Experience with software programs such as Phyton, Labview and/or Matlab.

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.

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.