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Job Title: Device Development Project Engineer-Design
Location: New Jersey, Hightstown
Discipline: Mechanical
Reference: CMMQ2151
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Description: mechanical device r & d/Design Control framework required by the FDA.
/ IVD Devices/3D CAD /CAE tools
CMMQ2151
Device Development Project Engineer-Design
Hightstown, NJ
Position is experienced mechanical design engineer to help a Pharamceutical
& Medical Device Company to design next generation handheld blood analysis
system. Work as a member of a Medical Device R&D team. The primary
role of this position will be to develop, design, document, and validate the
mechanical systems associated with our next generation blood analysis
system. In particular, it is expected that you will be responsible for the
aesthetic design, reliability, manufacturing processes, and cost of our
devices and peripherals. You will be responsible for CAD design, analysis
of strength and tolerances, producing drawings and specifications, design
verification, release documentation and aspects of product validation.
The work will be performed within the Design Control framework required
by the FDA.
Qualifications: Minimum Requirements .
--Education Requirements Bachelor's or Master of Science
in Mechanical Engineering
-Overall Related Experience , 10 years or more
-Strong working knowledge of 3D CAD design
including contoured, thin-walled geometry.
-Experience designing parts for injection molding, machining, stamping,
wire forming and other processes.
-Experience integrating electronic subsystems into handheld products
(boards, LCD displays, barcode scanners, battery power systems, etc.).
-Experience specifying/testing electronic interconnects (flat-flexible
cables, connectors, pogo pins, switches, keypads, etc.)
-Good laboratory skills (assembling prototypes, measuring mechanical
properties, developing jigs and fixtures, verifying performance).
- Experience using mechanical CAE tools (motion simulation, tolerance
analysis, stress analysis).
- Familiarity with safety testing/regulatory compliance for IVD Devices.
. Excellent written and verbal communication skills.
. Knowledge of MS Office documentation, spreadsheet, and presentation tools.
. Familiarity with medical quality systems and procedures.
Apply to: Click Here
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