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Title |
Location |
Type |
Rate |
Apply |
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Product Development Engineer |
West
Chester PA |
Perm/Full |
$65,000 - $80,000 |
Submit |
Product Development Engineer
Overview:
Designs and develops new implants and
instrumentation. This includes communication
with surgeons and sales consultants,
understanding the clinical issues, defining the
design parameters to support AO philosophies,
and ensuring the correct product is provided to
the customer
Responsibilities:
• Designs and develops new implants and
instrumentation and develops improvements and
modifications to current products.
• Interacts with surgeons, manufacturing,
regulatory affairs, sales consultants, product
managers, and other functional departments to
define and develop product requirements and
concepts.
• Works directly with surgeons for design
concept development, prototype and cadaver
evaluation, and clinical follow-up.
• Generates product models, concept layouts, and
prints using a CAD software. Apply geometric
dimensioning and tolerance accordingly.
• Performs the required activities and generates
the appropriate documents to ensure compliance
with FDA Design Control regulations, and to
support 510(k) submissions or IDE clinical
studies.
• Develops mechanical test protocols according
to ASTM standards and coordinates the activities
required to fabricate test parts and complete
mechanical testing.
• Works with manufacturing during the design
stages to incorporate manufacturability into the
product designs.
• Responsible for the all designs from concept
development through product launch.
• Responsible for initial patent review of
designs for freedom to operate.
• Know and follow all laws and policies that
apply to one's job, and maintain the highest
levels of professionalism, ethics and compliance
at all times.
• Diligently participate in our compliance
program-related activities as denoted by your
supervisor or our Chief Compliance Officer.
• Performs other special projects and functions
as assigned by the department manager.
Qualifications:
• Three to seven years experience in the design
and development of mechanical products.
• Knowledge of CAD software (Pro-E, Medusa,
AutoCad, Ideas, etc.).
• Prior project management experience preferred.
• Experience in medical equipment industry
desirable.
• Strong communication and interaction skills,
with the ability to interface with surgeons and
sales/marketing personnel.
• Demonstrated creative design ability.
• Demonstrated success in bringing product from
design through introduction on time.
• Hands-on� engineer.
• BS in Mechanical Engineering (or equivalent)
required.
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