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"Honesty,
Integrity and Reliability" -- The traits we value most in our
customers,
clients and most importantly – Ourselves
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Senior
R&D Engineer
Job
Description:
The position is for a senior-level mechanical engineer that will be
responsible for design and development of complex mechanical and
electromechanical subsystems. The ideal candidate will have
previous experience working in multi-disciplinary teams. The
position is for an independent, dynamic, hands-on design engineer who
can also work well as part of a larger team. The position may
also require managing contractors, and consultants to complete the
assigned projects.
Responsibilities:
· Design, develop and test
mechanical
components and electromechanical systems for a highly integrated class
II medical device.
· Design, test and document in
accordance with
medical design control regulations
· Develop projects from
prototype stage
through to manufacture
· Project management,
including specification
definition
· Participate in in-vitro and
animal testing
· Interface with physicians to
obtain user
feedback
· Provide appropriate testing
and
documentation to support 510(k) and IDE submissions
Qualifications:
· BS or MS in
Mechanical Engineering or
equivalent
· Creative, hands-on engineer
with 5+ years of
product development experience
· Strong analytic &
problem solving skills
· Good oral & written
communication skills
· Strong hands-on prototyping
skills
· Experience with SolidWorks
· Experience designing plastic
& metal
components
· Demonstrated familiarity
with the product
design cycle, from concept to market release
· Proficiency in verification
testing &
documentation
· Experience with project
management,
technical decisions & activity prioritization
· Experience with ISO
requirements, GMP
guidelines, FDA regulations and medical device design controls a plus
Preferred
Experience:
·
Work with
complex electromechanical systems
· Experience with flexible
endoscopes
· Experience in start-up
environment
If
you are interested in this postion, please visit our contact page
here
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