Technical Assessor - Active Medical Devices - Software and Devices controlled by Software
Posted on: November 20, 2023
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
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.
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:
- Assess / review client's technical documentation / medical
device files against the Medical Device Regulation EU 2017/745
- Interact directly with customers at all levels of management in
developing timely, complete, and accurate reports of their current
level of compliance and implementation of their technical
- Document and report assessment activities and results utilizing
analytical skills, technical knowledge, and excellent written
- Provide timely and accurate reviews of customer corrective
- Conduct assessments in accordance with established procedures,
maintaining a high standard of service delivery that ensures
effective customer relationships.
- Conduct Technical Documentation reviews specific to products
- Analyze complex regulatory requirements and make sound
determinations of the proper course of action.
- Work with minimal supervision with the ability to assess
compliance to regulatory requirements.
- Work independently or within a team environment utilizing
positive interactive skills.
- Maintain appropriate assessor credentials and pursue
advancement of those credentials and other related credentials as
- Complete all chargeable work within the required budget and
timeframes to ensure customer satisfaction and efficiency of the
What Is Required - What Makes a Successful Candidate:
Assessors shall have a university or technical college degree in a
relevant product or medical area, as described below:
- Biomedical Engineering or Bioengineering
- Mechanical Engineering
- Electrical or Electronics Engineering
- Computer or Software Engineering
- Medical Technology Experience:
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
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
Experience with Active Medical Devices may include design,
manufacturing, programming, testing, validation, or use of the
- Standalone software
- Medical Devices incorporating software, utilizing software,
controlled by software, including devices intended for controlling,
monitoring, or directly influencing the performance of active or
active implantable medical devices.
- Active (non-implantable) medical devices To be considered for
this role, you will have professional experience in the medical
device industry, in the field of healthcare products or related
activities, including but not limited to the following:
- Experience with software including direct, hands-on experience
with the development, programming, testing and verification and
validation of medical device software and / or medical devices
controlled by software.
- Direct, hands-on experience with design, development,
manufacture, testing and verification and validation of active
(non-implantable) medical devices.
- Work experience in medical devices industry or closely related
industries (e.g., pharmaceutical industry) in a research and
development, manufacturing, or quality engineering.
- Work experience in health services, universities, foundations,
or other institutions carrying out inspections, audits, clinical
evaluations, experimental and/or clinical research, including
- Work experience in the application of device technology and its
use in health care services and with patients.
- Testing devices for compliance in accordance with the relevant
harmonized, national or international standards.
- Experience in conducting pre-clinical testing or assessing
pre-clinical data with medical devices in one or more of the
following areas: (a) biological safety, physical, chemical, and
microbiological characterization, (b) Electrical safety and
Electromagnetic compatibility, (c) Software verification and
validation, (d) Stability and shelf-life, and (e) performance and
safety testing. General Expectations:
- Broad knowledge of engineering and technical applications used
in the development of medical devices.
- In depth knowledge of the Software life cycle processes for
medical device software (EN 62304).
- Excellent interpersonal, verbal, written and presentation
- Strong analytical skills while handling multiple projects,
delivering results on time using well developed problem-solving
- Pro-active attitude and excellent organizational skills and the
ability to work independently as well as within project teams.
- Strong background in either design engineering or R & D.
- Excellent working knowledge of medical device management
systems and medical device standards (harmonized, national and
international) for active medical devices and software.
- Experience with Risk Management (EN ISO 14971). Previous
experience as an Assessor with a Notified Body is not required.
We conduct a pre-employment background check and drug screen.
What We Offer:
- Generous Paid Time Off (Vacation, Company Holidays, Parental
Leave, Sick, and Disability).
- Multiple Medical, Dental, and Vision Benefit Plans to choose
- Spending Accounts - FSA, Dependent Care, Commuter Benefits,
- 401(K) with company match.
- Company provided life insurance, short-term, and long-term
- Education reimbursement program.
- Employer-Paid, therapist-led, virtual care services through
- Flexible work schedule with hybrid/remote opportunities.
Benefits may vary based on position, tenure, location, and employee
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
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
). Information received relating to accommodations will be
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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, Dallas , Technical Assessor - Active Medical Devices - Software and Devices controlled by Software, IT / Software / Systems , Dallas, Texas
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