This individual will apply sound engineering principles to the development of new products at Fresenius NxStage Medical Inc.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Collaborate with systems, electrical, disposable, and software engineers to create, test, and improve complex electro-mechanical components and assemblies for next generation home dialysis instruments. Components include pumps, motors, pneumatics, couplings, sheet metal housings, and PCBA mounting/cabling
Analysis of mechanical systems, including geometric tolerancing and Finite Element Analysis for structural, fatigue, thermal, vibration, and acoustics
Develop manufacturing drawings in accordance with applicable standards
Construct and test / oversee technicians in constructing and testing of prototype systems
Troubleshoot new designs and/or develop reliability improvements for existing designs
Improve designs for reliability, manufacturability, and performance
Participate in the development of product specifications and requirements documents
Support and/or conduct Risk Analysis activities, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) to ensure design- and process- related risks are identified and appropriately mitigated
Work with Quality Assurance to maintain documentation in accordance with the approved internal Quality System that meets applicable GMP, QSR, ISO13485, and other requirements
Support the design, development, testing, and/or use of complex automated and semi-automated assembly and test equipment
Manage vendors to insure rapid delivery of prototype components
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.
Occasional travel may be required, normally less than 10%
Bachelor s Degree required, MSME strongly preferred.
EXPERIENCE AND REQUIRED SKILLS:
4+ years of experience in product design, development, and/or testing of complex electro-mechanical products
Strong understanding of medical device development processes
Able to communicate effectively, both verbally and in writing
Strong diagnostic & problem-solving skills desired, including troubleshooting and root cause analysis
Experience maintaining the confidentiality of sensitive information
Experience with design of experiments
Familiarity with fabrication methods such as machining, molding, sheet metal, and casting processes
Demonstrated aptitude for practical application of mechanical, pneumatic, and electrical to system design. Design for EMI/ESD.
Prior medical device experience strongly preferred