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Title: R&D Engineer, Principal, Acclarent Inc. (Menlo Park, CA)
<mailto:careers@acclarent.com>careers@acclarent.com
(650) 687-4498 fax number
Job Summary:
Design and develop next generation mechanical and
electro-mechanical devices used in treatment of ENT disease.
Duties & Responsibilities:
· Lead conceptualization, design and
development of new devices with the intent of
commercialization per Quality System
Requirements. Also contribute to
design/development of product line extensions and product improvements
· Accurately and efficiently translate
user and patient needs through device design
requirements, design specifications, and into
verified/validated devices and procedures
· Lead in the generation of Intellectual Property
· Lead in design, development,
execution, and analysis of results of
system/device/component/material tests per laboratory best practices
· Collaborate with Clinical, Regulatory,
Quality, Manufacturing, etc. to ensure
development of innovative and reliable devices
that fulfill clinical needs within regulatory requirements
· Manage development partners and other
external vendors to meet project requirements and timelines
· Coordinate and execute Technical and
Peer Reviews. May also include coordination and execution of Design Reviews.
· May include leading verification and
validation activities through regulatory clearance and design transfer
· May involve direct or indirect
supervision of engineers and/or technicians
Qualifications:
Required Education and Experience:
· BS in Mechanical or Biomedical
Engineering (or equivalent experience)
· 5 years of experience in medical
device design, development, and commercialization
· 10 years of experience in design of
devices/mechanisms/machinery for industrial/commercial/consumer use
· 10 years experience designing with 3D CAD tools
· Track record of Intellectual Property generation
· Experience designing and developing handheld mechanical devices
· Knowledge and application of broad
range of component and assembly manufacturing
methods (e.g. molding, machining, sheet metal
stamping and forming, laser cutting and welding,
extrusion, drawing, bonding, etc.)
· Rapid prototyping skills (e.g. hands-on prototyping, SLA/FDM, etc.)
Desired Qualifications:
· MS in Engineering with 10 years of
direct medical device experience in Class II or Class III
· SolidWorks proficiency
· Basic machine shop skills (e.g. mill, lathe, saw, grinder, etc.)
· Experience in lead role delivering
successful projects from concept through commercialization
· experience collaborating directly with
clinicians to translate clinical, patient, and
user needs into validated device designs
· Experience designing and developing
handheld electro-mechanical devices
· Experience designing and developing
devices incorporating electrical hardware and software
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Potential applicants should communicate directly
with the contact listed in the posting. Please
do not "reply" to the posting messages.
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