Summary:
This position requires an individual who has
demonstrated 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. This
position requires the skill to interact with a
variety of internal and external parties
including engineers, research scientists, quality
assurance, machining vendors and contract manufacturers.
• Provides substantial individual
technical contribution to the development of new
medical device product(s) for drug delivery from
initial design to market release
• Investigates/evaluates existing
technologies and drives consensus for
implementation among engineering staff to ensure effective product development
• Designs and implements new
methodologies, materials, devices or processes
• Designs and/or conducts feasibility
studies of the design to assess ability to function as intended
• Maintains detailed documentation
throughout all phases of research and development
• Coordinates activities with outside
suppliers and consultants to ensure the delivery
of supplies or services needed to meet scheduled timelines
Essential Duties and Responsibilities:
• Resolves a wide range of design
issues in imaginative as well as practical ways
• Works on complex technical issues
where analysis of situations or data requires an
in-depth evaluation of identifiable and/or variable factors.
• Communicates past and projected
progress towards milestones and cost targets to
assist in the management of device projects
• Demonstrates good judgment in
selecting methods and techniques for obtaining solutions.
• Interacts with senior internal and external personnel.
• Interacts with other engineers and
scientists in the development of novel instrumentation, devices and equipment.
• Provides problem definition by
performing technical analysis and presenting solutions for review.
• Proposes design ideas for the
introduction of new measurement, device and process technologies.
• Conceives primarily
mechanically-oriented design solutions, but may
possibly also involve electro-mechanical,
electronic, optical and computer-controlled capabilities.
• Drafts and prototypes design
concepts, implements in manufacturable form.
• Selects and specifies parts based on engineering analysis.
• Builds, tests and modifies device
prototypes in a laboratory setting.
• Programs computers with data
acquisition and instrument control capabilities.
• Documents work with clearly written
reports and well organized design files.
• Communicates results in verbal presentations.
• Fully documents product
improvements within ISO and cGMP guidelines.
• Works closely with manufacturing,
tooling engineers, and contract manufacturers to
transfer designs to manufacturing.
• Performs tolerance analysis and
uses GD&T as needed to properly control design and manufacturability.
• Provides technical support for device commercial production.
• Works with product teams and
customers to refine designs for specific applications.
• Develops relationships with key vendors and production shops.
• Creates innovative and economic
design solutions utilizing Design for Manufacturability/Assembly targets.
• May assist in project management tasks
• May direct the work of technicians or junior engineering staff.
Minimum Qualification Requirements:
• A minimum of a Bachelor’s degree in
an Engineering discipline is required. Equivalent experience may be accepted.
• A minimum of 5 years industry work experience is required.
• A minimum of 2 years of 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 required. Read
http://www.fda.gov/cdrh/comp/designgd.pdf before applying.
• Demonstrated competence using a
solid modeling computer aided design software
such as Pro/Engineer or SolidWorks is required.
• Good computer skills are required.
Lab view, and other engineering software is a plus.
• Relevant experience with Finite
Element Analysis (FEA), Computational Fluid
Dynamics (CFD) and other simulation analysis software is a plus.
• Must possess mechanical aptitude,
sound technical judgment and use structured decision-making techniques.
• Must be a mechanical 'hands-on'
person with the ability to operate in R&D
laboratory environment in support of research experiments.
• Must have an ability to provide
technical engineering support and influence the
work of others in a collaborative, team-oriented project environment.
• Knowledge of high volume and
prototype materials, processes, and other manufacturing techniques is required.
• Good oral and written communication skills are a must.
• Previous supervisory experience is a plus.
Apply online at
<
https://sjobs.brassring.com/2057/ASP/TG/cim_jobdetail.asp?partnerid=13617&siteid=5260&jobid=1986700&codes=novcom>
https://sjobs.brassring.com/2057/ASP/TG/cim_jobdetail.asp?partnerid=13617&siteid=5260&jobid=1986700&codes=novcom
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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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Received on 2012-11-20 12:25:43