Senior Quality Engineer - Catheters
Company: Penumbra
Location: roseville
Posted on: May 3, 2021
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Job Description:
What You'll Work On * Represent Quality Engineering on cross-functional teams,
interfacing among multiple departments and teams such as
Manufacturing, QC, R&D, Regulatory Affairs,
Operations/Planning, and Marketing. * Review and approve
engineering change orders on assigned projects and product lines. *
Plan, design, and implement test methods, including test equipment,
for inspection of product. * Evaluate, update, and improve
difficult manufacturing processes and engineering systems for
assigned product lines. * Work with suppliers to continually
improve technical processes, reliability, and inspections to meet
Penumbra's quality standards. * Take the lead on drafting and
implementing risk analysis documentation for new and current
products with identified hazards and harms. * Provide leadership
and guidance, in the scope of quality systems, to ensure compliance
within designated projects and product lines. * Lead nonconforming
report investigations and recommend appropriate corrective actions.
* Identify the need for Corrective Action Preventative Action
(CAPA). Initiate, implement, and close CAPAs. * Apply statistical
rationale to plan, analyze, and interpret engineering test data
collected during new testing. * Provides leadership and mentoring
to more junior staff. May supervise junior engineers. What You Bring * A passion for detailed analysis and problem solving. * A knack
for solving mechanical problems effectively. * The desire to be
part of a great team and to represent Quality Engineering on
cross-functional technical teams. * The ability to present issues,
plans and objectives in a clear, compelling way, both orally and in
writing. * Versatility, flexibility, and a willingness to work
within constantly changing priorities. * Broad knowledge of
applicable regulations and standards, e.g. QSR, ISO 13485. * Solid
knowledge of sterilization, biocompatibility, and transportation
and shelf life standards * Working knowledge of data collection,
data analysis, and evaluation, and scientific method. * Bachelor's
degree in an engineering or scientific field, plus 4-6 years of
experience in biomedical, mechanical, chemical, or materials
engineering. * ASQ CQE preferred. What We Offer * A collaborative teamwork environment where learning is
constant and performance is rewarded. * The opportunity to be at
the forefront of technology that is revolutionizing the treatment
of some of the world's most devastating diseases. * A generous
benefits package that includes medical, dental, vision, and life
insurance; a 401(k) match; and an Employee Stock Purchase Plan. A collaborative teamwork environment where learning is constant
and performance is rewarded. The opportunity to be at the forefront of technology that is
revolutionizing the treatment of some of the world's most
devastating diseases. A generous benefits package that includes medical, dental,
vision, and life insurance; a 401(k) match; and an Employee Stock
Purchase Plan. If you reside in the State of California, please also refer to
Penumbra's Privacy Notice for California Residents.
Keywords: Penumbra, Roseville , Senior Quality Engineer - Catheters, Other , roseville, California
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