? Do you have a passion for designing clever little mechanisms in
tight spaces?
? Does the prospect of making a major contribution to a medical device
that can improve the lives of millions of people get your juices
flowing?
? Are you a budding Pro/E expert with significant experience in
designing highly manufacturable plastic parts?
? Do you want the sense of ownership that comes with seeing a product
through from concept all of the way through to high volume production?
Novartis Pharmaceuticals has an opening on our Device Development team
in San Carlos. You will work alongside some of the world?s experts in
aerosol drug delivery device design to create an innovative family of
dry powder inhalers to treat local lung diseases such as asthma,
cystic fibrosis (CF) and chronic obstructive pulmonary disorder
(COPD). We are setting the bar for the industry in terms of
efficiency, ease of use, ease of manufacture and time to market. All
of this without losing sight of the importance of emotional appeal and
the unmistakable feel of a quality product.
This position requires an individual with a unique combination of
skills and temperament ? able to rapidly iterate and realize clever
design concepts to solve challenging and nuanced problems while
producing these results in a disciplined, well-documented manner.
What we do is deceptively difficult and requires a considerable amount
of insight and creative thinking to produce an elegant solution. Our
team is very experienced, and we are looking for someone who wants the
chance to learn from and be mentored by talented (and friendly!)
engineers who have been around the block a few times, while still able
to step in to contribute meaningfully right away.
This position requires the skill to interact with a variety of
internal and external parties including engineers, research
scientists, regulatory affairs, quality assurance, machining vendors
and contract manufacturers.
Responsibilities and Duties
? Resolve a wide range of design issues in imaginative as well as
practical ways.
? Provide problem definition by performing technical analysis and
presenting solutions for review.
? Conceive primarily mechanically-oriented design solutions, but may
possibly also involve electro-mechanical, electronic, optical and
computer-controlled capabilities.
? Drafts, prototypes and implements mechanical design concepts.
? Build, test and modify device prototypes in a laboratory setting.
? Develop test and release methods and fixtures to ensure product
robustness and reliability.
? Select and specify parts based on engineering analysis.
? Document work with clearly written reports and well organized design files.
? Understand and follow Novartis Standard Operating Procedures.
? Communicate results in verbal presentations.
? Work closely with manufacturing, tooling engineers, and contract
manufacturers to transfer designs to manufacturing.
? Perform tolerance analysis and use GD&T as needed to properly
control design and manufacturability and communicate design intent.
? May direct the work of technicians.
Requirements
? A minimum of a Bachelors degree in an engineering discipline is
required, mechanical or biomedical engineering strongly preferred.
Equivalent experience may be accepted.
? A minimum of 2 years industry work experience is required.
? A minimum of 1 years experience in a medical device design
environment or other regulated environment is preferred.
? Familiarity with the basic principles of FDA Design Control (21 CFR
820.30) is expected. If you do not have direct experience, please
read http://www.fda.gov/cdrh/comp/designgd.pdf before applying.
? Must possess sound technical judgment, demonstrate mechanical
aptitude and use structured decision-making techniques.
? Good oral and written communication skills are essential.
? Demonstrated competence using Pro/Engineer (Wildfire 2.0 or later)
solid modeling computer aided design software is required.
? Knowledge of machining and other manufacturing techniques is
required. Knowledge of high volume and prototype materials, processes
and techniques preferred.
? Must be a mechanical 'hands-on' person with the ability to operate
in R&D laboratory environment in support of research experiments.
? Good computer skills are required. Experience with Labview and other
engineering software is a plus.
Contact (principals only, please):
David Maltz
Novartis Pharma
San Carlos, CA
david.maltz@novartis.com
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