job_021711a: Medical Device Product Development Engineer, Loma Vista Medical (Burlingame, CA)

From: Kristin Burns <kristin.burns_at_stanford.edu>
Date: Thu, 17 Feb 2011 10:29:38 -0800

TITLE: Product Development Engineer


SUMMARY
We are seeking a compelling candidate who can
develop products and processes that significantly
advance Loma Vista Medical’s (LVM) clinical and
market success. The ideal candidate would
display the ability to perform to the below
requirements, would show a high level of
individual responsibility, and would act with
passion and intensity in a VC-funded medical
device start-up that is fast-paced and
collaborative. We are located in Burlingame, CA.

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.
* Interfacing with clinicians to ensure that customer requirements are met.
* Specifying and modifying manufacturing equipment.
* Creating packaging configurations.
* 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.
* 6+ years of work experience as a product development engineer.
* Minimum of 3 years of work experience in 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.
* Strong clinical background with a thorough
knowledge of anatomy & 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 – including
2+ years work experience - highly desirable.
* Experience with electronics, circuits, etc.
* Experience with writing simple software, such
as for microcontrollers or a PC.
* 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: alex (at) lomavistamedical.com

- - - - - - - - - - - - - - - - - - -
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with the contact listed in the posting. Please
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Received on 2011-02-17 10:29:24

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