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If you are interested in the position, feel free to place your “bid” on
line: www.careers.jnj.com and search for the requisition by using the
number – 7217110506
PRINCIPAL ENGINEER (POLYMERS) ADVANCED PROCESS (7217110506) at Biosense
Webster Inc.
Job Description
Biosense Webster, a member of Johnson & Johnson's Family of Companies, is
recruiting for a Principal Engineer, Advanced Process, located in Irwindale,
CA.
Biosense Webster, Inc. is recognized worldwide as an industry leader in
endocardial diagnostics and therapy. Guided by the needs of
electrophysiologists and cardiologists, the company has pioneered innovative
technological advancements ranging from the first deflectable tip catheter
to today's most sophisticated three-dimensional cardiac mapping and
navigation systems. Biosense Webster, Inc., combines leading-edge technology
with a tradition of quality and responsiveness while partnering with the
physician to optimize patient outcomes.
The Principal Engineer will be responsible for working as hands on engineer
on projects in the area of plastics extrusions, injection molding, polymers
and adhesives development, and electrode materials testing and
characterization. This individual will provide technical support in the
development and improvement of injection molded catheter parts. The
Principal Engineer will assess and mitigate manufacturing deficiencies in
the extrusion area. This individual will act as a liaison between extrusion
, inner company departments and OEM. They will perform process analysis,
improvements and process validation (IQ/OQ/PQ) and work with cross-
functional teams to move pilot operations into production.
The Principal Engineer will apply process excellence tools in conducting
root cause analysis of manufacturing extrusion and mold injections problems.
They will write Engineering Change Orders to ensure proper justification
and documentation of changes and generate engineering requirements, cost
estimates, and schedules and will work with manufacturing to implement new
product development projects. This individual will work closely with
Quality/Regulatory/R&D and Manufacturing to achieve FDA approval and
transfer into manufacture. The Principal Engineer will interface with
outside suppliers as needed, and be responsible for ensuring personnel and
company compliance with all Federal, State, local and company regulations,
policies and procedures for Health, Safety and Environmental compliance.
The work environment characteristics described here are representative of
those an employee encounters while performing the essential functions of
this job. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions. While performing the
duties of this job, the employee regularly works near moving mechanical
parts. The employee is frequently exposed to risk of electrical shock. The
employee is occasionally exposed to fumes or airborne particles and toxic or
caustic chemicals.
Qualifications
This position will require a minimum of a BS Degree in Mechanical or Polymer
Science and Engineering and 10 years of relevant experience in the medical
device industry. A PhD in Polymer Science and 5 years of relevant experience
in the medical device industry is preferred. Any direct experience with
catheters is preferred.
It is required that the Principal Engineer has a working understanding of
extrusion manufacturing; injection molding, heat shrink process, adhesive
and applications, and materials properties and process relationship
characterization.
Project Management experience through the entire product development life
cycle is required. Hands on experience in polymer molding, material
sampling and SPC practices, in addition to FMEA, DOE and process capability
studies is required. A working knowledge of cost reduction techniques such
as DFM is required.
Knowledge of FDA and ISO regulations is required. Candidates who possess
knowledge of GMP and other regulatory requirements are desired. Design
experience using Solid Works and/or AutoCAD is also desired. Candidates who
possess knowledge of melt indexes on polymers and adhesives is a plus.
The ability to use a PC and associated software is required. In addition
candidates are required to have proven leadership abilities and a thorough
understanding of project management. This position will require strong
technical and troubleshooting skills, as well as the ability to influence
others.
This position will require approximately 15% travel and will be based in
Irwindale, CA. |
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