Technical Assessor - Active Medical Devices - Software and Devices controlled by Software
Company: DNV
Location: Dublin
Posted on: November 20, 2023
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Job Description:
Local Unit & Position Description
DNV Supply Chain and Product Assurance has immediate openings on
our growing Medical Device Team!
DNV Supply Chain and Product Assurance is looking to recruit
technical and experienced personnel to be Active Medical Device
Assessors throughout North America with expertise specific to
stand-alone software and/or medical devices controlled by software.
This position can be remote from anywhere in the Continental
U.S.A.
The successful candidate(s) will be responsible for conducting
product reviews of client technical documentation, in accordance
with the Medical Device Regulation (EU 2017/745), enabling the
delivery of certification services that meet customer requirements
and appropriate accreditation standards.
Job Summary:
Individuals in this role must have successfully completed a
university or technical college degree in the following or similar
degree fields: Biomedical Engineering, Mechanical Engineering,
Electrical / Electronics Engineering, Computer / Software
Engineering or Medical Technology.
This role requires 4-years of professional experience working in
the medical device industry, in the field of healthcare products or
related activities. Professional experience must include at least
2-years in the design, manufacture, testing or use of the medical
device or technology to be assessed or related to the scientific
aspects to be assessed.
The successful candidate possesses knowledge and understanding
covering a wide range of medical device technologies and hands-on
experience in the development, manufacturing / programming, testing
and validation of medical device software and / or medical devices
controlled by software.
What You'll Do:
Position Qualifications
What Is Required - What Makes a Successful Candidate:
Education:
Assessors shall have a university or technical college degree in a
relevant product or medical area, as described below:
In addition to a relevant educational degree, candidates must have
a minimum of 4-years work experience (full time) in a medical
device related industry, with at least 2 of these years in the
design, manufacturing, testing or use of the device in which they
are qualified to assess, and/or experience as an assessor at a
notified body five full technical documentation assessments
completed .
A Ph.D. in a relevant area for medical devices can substitute
3-years of work experience if it includes at least 2-years of
experience in the design, manufacture and/or testing of medical
devices.
Experience with Active Medical Devices may include design,
manufacturing, programming, testing, validation, or use of the
following devices:
We conduct a pre-employment background check and drug screen.
What We Offer:
How We Do It:
We Care, We Dare, We Share
DNV is a proud equal opportunity employer committed to building an
inclusive and diverse workforce. All employment is decided on the
basis of qualifications, merit or business need, without regard to
race, color, religion, age, sex, sexual orientation, gender
identity, national origin, disability or protected veteran
status.
DNV is committed to ensuring equal employment opportunity,
including providing reasonable accommodations to individuals with a
disability. US applicants with a physical or mental disability who
require a reasonable accommodation for any part of the application
or hiring process may contact the North America Recruitment
department (
). Information received relating to accommodations will be
addressed confidentially.
DNV is proud to announce being named one of Houston's best places
to work in the 2022 Houston Business Journal - Best Places to Work
competition.
For more information about your rights under the law, see:
Read
more here:
Diversity at DNV
Meet our Employees
About DNV
Careers in DNV
As required by the Pay Transparency laws in Colorado, New York
City, California, and Washington, DNV provides a reasonable range
of compensation for roles that may be hired in those locations.
Actual compensation is influenced by a wide array of factors
including but not limited to skill set, level of experience, and
specific office location. For the state of Colorado, New York City,
NY, California . click apply for full job details
Keywords: DNV, Columbus , Technical Assessor - Active Medical Devices - Software and Devices controlled by Software, IT / Software / Systems , Dublin, Ohio
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here to apply!
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