COVIDIEN – $77,355.00/Year

The Senior RD Engineer position requires a Masters degree in Mechanical, Industrial, Biomedical or Electronics Engineering and two 2 years of experience in RD engineering. The position requires a minimum of two 2 years of experience with each of the following Product Design, Process Development and Manufacturing and Quality control of Class II and Class III medical devices involving catheters; FDA QSR, CFR 820, ISO13485, ISO14971 and EU Medical Device Directive; risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis and CAPA; analyzing Postmarket surveillance, investigating and responding to complaints; Measurement System Analysis, Design of Experiments and Statistical Process Control, Process Capability and Sampling Techniques; Development of Installation Qualification IQ, Operation Qualification OQ, Performance Qualification PQ, Gage RR and Test Method validations TMV; and Good Manufacturing Practices GMP and Good Documentation Practices GDP. Multiple positions available.