job_110911a: Sr. Human Factors Eng, Novartis (San Carlos, CA)

From: Kristin Burns <>
Date: Wed, 09 Nov 2011 07:04:45 -0800


Sr. Human Factors Engineer - San Francisco Bay Area – Job ID 89365BR

Novartis Pharmaceuticals has an exciting
opportunity for a Senior Human Factors Engineer
to support our rapidly growing product pipeline.
We are looking for a detail-oriented, energetic
self-starter with strong expertise in human
factors engineering for drug delivery devices,
with demonstrated ability to successfully lead
human factors activities within medical device
development projects. The position offers
opportunities to work in multidisciplinary and
international teams, across projects, where your
specific contribution within human factors
engineering is a key element for success.
Management of external partners is also an important part of the role.

The successful candidate will be responsible for
independently leading the planning, execution and
reporting of human factors and user interface
design studies, according to current regulations
and guidelines within the medical device and
pharmaceutical industries. The Senior Human
Factors Engineer will also provide expert input
to device and packaging design teams to establish
system design, operating and training
requirements and to ensure that human factors
engineering concepts are incorporated early in
development. Will also act as a key advocate for
these principles across the company.

Minimum requirements
• A minimum of a Bachelors degree in Mechanical
Engineering, Bioengineering, Psychology, or
related discipline/specialty in Human Factors
• A minimum of 8 years industry work experience.
• A minimum of 3 years experience in a medical
device or pharmaceutical packaging design
environment, at least 5 years preferred.
• Thorough understanding of design requirements
for design, development, validation, and verification of medical devices
• Proven experience in the development of HFE
principles of ergonomics, human computer/machine
interface, and data collection/analysis methodologies
• Thorough knowledge of relevant human factors
regulations, standards and guidances for medical
devices and pharmaceutical packaging.
• Working understanding of the principles of
Medical Device and healthcare regulations
including FDA’s Quality System Regulation (QSR), ISO 13485:2003, etc.
• Experience in design of formative and summative
human factor studies to address the needs of the
requirements setting, design testing,
verification and validation stages of device development.
• Experience in writing human factors engineering
protocols and reports as support for registration
documentation (e.g. Usability engineering reports).
• Excellent presentation and scientific writing skills.
• Proven leadership and project management skills .
• Experience in management of external partners.

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with the contact listed in the posting. Please
do not "reply" to the posting messages.

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Received on 2011-11-09 07:04:39

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