Acclarent, Inc., a member of Johnson & Johnson's
Family of Companies, is recruiting for a Senior
Quality Engineer, Product Development, located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in
Menlo Park, CA that was established in June of
2004. The company is dedicated to the development
of innovative devices providing new technologies
to further meet the needs of ENT patients.
Acclarent's initial focus is on achieving the
goals of sinus surgery with novel, endoscopic,
catheter-based tools - Balloon Sinuplasty™
devices. Through the Balloon Sinuplasty™
technology and our RelievaŽ product portfolio we
offer ENT patients another option to conventional
endoscopic surgical technologies. FDA clearances
for these devices were completed in 2005 and the
products were commercially launched in the US that same year.
Through our core technologies and commitment to
innovation, Acclarent will continue to advance
novel devices in all areas of ENT.
The Senior Quality Engineer, Product Development
represents the Quality Assurance function on
product development teams from early design
stages to product implementation in
manufacturing. This individual develops and
executes the Quality plan for each product
development stage. They ensure that product
development projects are conducted in compliance
with internal, customer, and regulatory
requirements. The Senior Quality Engineer reviews
new and modified product designs and process
documentation for quality attributes, including
manufacturability, serviceability, testability,
reliability, and conformance to product and
quality system requirements. This individual
demonstrates product compliance to internal,
customer, and regulatory requirements for
sterilization, biocompatibility, package
integrity, shelf life, and reliability.
Activities include creation of protocols and
reports, test vendor qualification, and testing
management. This individual also manages the
development and maintenance of product risk management files.
The Senior Quality Engineer, Product Development
oversees design verification testing, and leads
test method assessment and validation activities.
This individual develops requirements for first
article inspection, incoming and in-process
inspections, and lot release testing, including
sampling strategy and test methods. They also
conduct failure investigations to analyze
internal system or process failures, and
implement corrective and preventive action. The
Senior Quality Engineer participates in component
and service supplier evaluation, including
supplier audits. This individual works with
suppliers to ensure appropriate quality controls
are implemented. They review lot documentation
and release product for clinical use. The
individual audits Design History Files, and
identifies and implements best-in-class quality
engineering practices, including statistical
methods and root cause analysis tools. This
individual guides product development teams on
efficient and effective application of design controls.
A minimum of a Bachelor's degree in an
Engineering-related discipline is required. A
minimum of 5 years of professional experience in
a medical device manufacturing and product
development environment is required. A working
knowledge of the FDA Quality System Regulation,
ISO 13485, and the EU Medical Device Directive is
required. The incumbent must be skilled in the
implementation of ISO 14971, including risk
evaluation techniques, such as FMEA or fault tree
analysis. It is preferred that this candidate be
familiar with test methods and standards for the
design, verification, and validation of medical
device products, including sterilization,
biocompatibility, packaging validation.
It is required to be experienced in test plan
development and root cause failure analysis. It
is highly desired that this individual be skilled
in the application of statistical methods,
including ANOVA, statistical process control,
sampling plans, gauge R&R, design of experiments,
and reliability demonstration. Excellent verbal
(including presentation) and written
communication skills, especially technical report
writing, are required. The incumbent must have
the ability to work effectively on project teams.
ASQ CQE certification is a plus.
This position may require minimal (0 -10 %)
travel and is located in Menlo Park, CA.
BE VITAL in your career, Be seen for the talent
you bring to your work. Explore opportunities
within the Johnson & Johnson Family of Companies.
Karen Stafford
Team Member, Sourcing
Acro Staffing, providing services for
Johnson & Johnson Global Recruiting
kstaffo1_at_its.jnj.com
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Received on 2013-04-11 14:53:54