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Job description (Tasks/Responsibilities):
* Participate as part of the risk management group to assess
the risks associated with the use of Respironics products and services. This
requires knowledge and experience with risk assessment standards and practices
associated with medical devices.
* Will be expected to create risk assessment documents and
post market risk assessment documentation per the Respironics Quality System
procedures.
* Will be expected to lead risk assessment discussions as a
risk management process expert.
* Possess technical background in order to understand the
design and operation of electromechanical medical devices.
* Will help to identify product design requirements
necessary to sufficiently control risk associated with medical devices.
* Will also be responsible to collect and analyze data and
assess the actual risk of devices in the field against assessed risk to
determine if risks are adequately controlled.
Skill Requirements:
BS in engineering or technical science. 3-5 years experience assessing risks associated with
medical devices in accordance with ISO 14971 is highly desired. Familiarity with failure analysis type tools such as FMEA,
Fault Tree Analysis, and Probabilistic Risk Assessment is desired. Experience with risk control practices is desired.
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Company Description:
Respironics, a
worldwide leader at anticipating needs and providing valued solutions to the
sleep and respiratory markets.The
company's focus is on home care, hospital, respiratory drug delivery and
international markets providing programs that manage sleep disordered
breathing, chronic obstructive pulmonary disease, asthma, infant care,
congestive heart failure and restrictive lung disorders. Globally positioned
has manufacturing facilities in several domestic and international markets.
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