Intel Corp is looking for a regulatory engineer.  The posting is as follows. 

 

Please do not contact me as I will not reply to questions about the position. 
If you are interested contact the online Intel Jobs tool or Monster Jobs and
post against this information.

 

Regards.

 

 

Posting Title:  Digital Healthcare Product Regulatory Engineer

 

Location:  Oregon, Portland or California, Folsom

 

 

The Digital Health Group’s (DHeG) goal is to enable accelerated innovation
in healthcare, and lower the cost of healthcare technology, by extending
Intel’s core capabilities and products to provide healthcare-specific
solutions.

Specifically in the healthcare IT space, the group is driving the use of
technology to empower providers to deliver the highest quality of care, and
extend the reach of healthcare across the globe.

DHeG is looking for highly skilled individuals to join our dynamic team.

 

Responsibilities

 

The successful candidate will ensure the safety, functionality and
interoperability of Intel Digital Healthcare’s products in medical
environments.  The Product Regulatory engineer will work with Intel platform
designers, component suppliers, customers, medical instrument suppliers, DHeG
Regulatory Affairs, and regulatory agencies to ensure our ITE and Medical
Devices are designed and certified to meet the regulatory requirements for the
world market.  Should regulatory issues occur, the candidate will determine
the root cause, suggest methods to alleviate or mitigate the problems, and
provide feedback into the design processes. Candidate will coordinate and
provide testing support to obtain all required regulatory certifications for
target markets.

 

Qualifications

 

Candidate must possess a Master or Bachelor of Science degree in Electrical
Engineering or Computer Engineering along with seven or more years of
experience resolving safety and EMC issues at the board and systems levels.
Candidate must be able to successfully integrate into design teams and provide
regulatory guidance on design trade-offs and impacts. Must be able to work in
a very fast-paced environment and deal with ambiguity, while ensuring
standards for safety are met and products can be certified for their intended
usages and markets. Excellent verbal and written communications skills
required. Candidate must be highly organized and have attention to detail. 

 

Additional technical qualifications include:

-         Required – Solid working knowledge of regulatory body standards
and requirements (FCC, FDA, UL, EU, et al)

-         Required – Proven ability to achieve world wide safety
certifications for Medical and ITE Devices.

-         Required – Safety design and debug at a board and system levels
for Medical Devices and ITE.

-         Required – Detailed knowledge with the following standards IEC/UL
60601-1, IEC/UL 60950-1, IEC/UL 60601-1-1 and IEC/UL 60601-1-4.

-         Required - Familiarity with laboratory test equipment usage and
calibration: DMMs, o’scopes, and spectrum analyzers

-         Desired - experienced working in an ISO 9000 or ISO 13485 environment

-         Desired - EMC/EMI board and system level design and debug for ITE
and/or Medical Devices.

-         Desired - experience as part of a design team developing products
for the health care field is a definite plus

 


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