TITLE: Senior Product Development Engineer
COMPANY:
Loma Vista Medical (LVM) is an innovative,
Silicon Valley-based, venture capital-funded
medical device start-up. LVM creates and sells
the world’s most advanced medical
inflatables. Our initial product is a
category-defining flexible composite balloon for
the rapidly growing TAVI (Transcatheter Aortic
Valve Implantation) market. The product is CE
marked, is selling in Europe, and is highly
praised by opinion-leading cardiologists. LVM is
based in Burlingame, California.
ROLE:
We are seeking a compelling candidate who is
results-oriented, trustworthy, efficient,
thoughtful, knowledgeable, highly motivated, and
both proactive and responsive. The individual
will work within a fast-paced multidisciplinary
team environment to manage and develop products
and processes that significantly advance Loma
Vista Medical’s clinical and market success. The
ideal candidate would demonstrate the ability to
perform to the below requirements, would show a
high level of individual responsibility, and
would act with passion and intensity.
JOB DUTIES AND RESPONSIBILITIES:
• Independently managing projects
from start-to-finish, from new concepts through to market release.
• Developing novel concepts leading to an
enhanced intellectual property portfolio.
• Designing on CAD and then following thru to
manufacture, utilization & characterization,
next-generation equipment & devices.
• Developing test methods, protocols, reports
and conclusions to evaluate components, processes and assemblies.
• Creating manufacturing documentation,
including Manufacturing Process Instructions, Bills of Materials and Travelers.
• Performing analytical calculations.
• Conducting training with manufacturing personnel.
• Working closely with vendors and subcontractors.
• Working closely with Q/A to develop standards,
perform verification and validation testing,
perform failure analysis, and to continuously
improve the company’s products and processes.
• Working effectively within the confines of a
regulated, quality-system driven, FDA monitored medical device environment.
• Working closely with clinicians to understand
clinical needs leading that lead to product specifications and risk analyses.
• Specifying and modifying manufacturing equipment.
• Developing prototypes, jigs, and fixtures in a machine shop.
• Creating manufacturing methods that are
developed, characterized, bounded and repeatable.
ESSENTIAL REQUIREMENTS:
• B.S. or M.S. in Mechanical
Engineering. Related degrees are acceptable but
you should be able to describe to convince us
that you are very competent doing what a mechanical engineer does.
• 5+ years of work experience as a
hands-on product development engineer.
• Passionate about medical devices.
• A willingness to work hard, with a
driven outlook and with a strong desire to
succeed as an engineer, as a team, and as a company.
• An inventive aptitude, balanced
with discipline and detail-orientation.
HIGHLY DESIRABLE SKILLS:
• Developed products from invention
to market release. Give us some examples!
• Experience in a start-up
environment wearing multiple hats. What is the
best part of start-ups for you? What is the worst?
• Experience with medical device manufacturing.
• Minimum of 2 years of work
experience in medical devices is highly desired.
• Strong clinical background with a
thorough knowledge of anatomy and disease,
exposure to doctors, and surgical procedure
development. Do your current professional contacts include MDs?
• Experience creating and managing
schedules, budgets, and plans. Give us an example!
• Experience with medical device
quality systems, V&V studies and regulatory filings.
• Expertise in the area of catheters is desirable.
• Experience with electronics, circuits, etc.
• Experience with writing simple
software, such as for microcontrollers or a PC.
• Experience with industrial design
and product design. Have you worked on issues
such as usability, need finding and product appearance?
• Proficient with SolidWorks.
• Particular expertise in the area of
materials - including polymers - is desirable.
• Made significant contributions to
an IP portfolio. Can you cite any pending or issued patents?
PLEASE SEND US:
• A short cover letter showing us
that you have read this ad and are responding to
our needs. This really matters! Tell us, briefly,
why you could be great in this role.
• Your resume.
• Ideally, some samples of your work.
This could be a link to a website, a portfolio in
PDF or word, some JPGs or whatever you think can
give us a sense for what you have done.
• Send to: Mark Scheeff, VP of
Product Development: mark (--at--) lomavistamedical.com.
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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 2012-06-20 19:21:07