SR. PROCESS DEVELOPMENT ENGINEER, SHIFAMED (CAMPBELL, CA)
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Develop mechanical aspects of
manufacturing processes by applying engineering
knowledge and product design, fabrication, assembly, tooling and materials
· Understand how to program, trouble
shoot and replace tools on Nanotech lathes to support production needs.
· Perform process optimization and
manufacturing scale-up; primarily focused on the lathe machining area.
· Design and validate fixtures and tools
for manufacturing and inspection processes and
optimize to reduce requirements for operator skill.
· Research, develop, modify and test
manufacturing methods and equipment; perform
IQ/OQ/PQ validations and gauge R&R.
· Improve manufacturing efficiency
through planning and evaluation of work flow,
space requirements and equipment layout.
· Provide day-to-day manufacturing
support and decision-making; troubleshoot
assembly process issues as necessary; respond
with urgency to process and equipment issues.
· Assure product and process quality by
designing test methods, performing process
validations and process capability studies.
· Establish and maintain manufacturing
and inspection procedures; prepare process
validation protocols and reports; execute process
validations; collect and analyze process data and trends and implement changes.
· Drive and provide support to quality
processes and applying formal problem-solving
techniques to determine root cause, and
implementing solutions (non-conformance, CAPA,
change management, audits, product complaint investigations, etc.).
· Provide training to associates,
technicians and operators; assisting other technical associates.
· Design, execute, and analyse
experiments using sound statistical methodology.
Participate in risk management activities,
including development and ownership of process FMEAs.
· Utilize required Quality System
procedures; adhere to the Quality Policy and
quality system requirements, including maintaining accurate documentation.
· Support product verification and
validation activities by developing test protocols and writing test reports.
· Support company goals and objectives,
policies and procedures, and regulatory
requirements (FDA regulations, ISO 13485, MDD, etc.).
· Other duties as assigned.
EDUCATION/EXPERIENCE:
· Bachelor’s in Mechanical Engineering,
Industrial Engineering or equivalent experience.
· 5- 8 years of previous medical device
experience, preferably in ophthalmology industry.
· Ability to program, set up and run C
axis CNC machines demonstrating micron
dimensional control. Ability to optimize tools
paths moving from prototype to volume production.
· Experience building fine assemblies
using complaint materials, experience with
hydrophilic acrylic materials is preferred.
· Experience developing and executing
process and/or equipment validations.
· Proven ability to prioritize, initiate,
and drive projects to completion.
· Experience with quality system
documentation requirements and test protocols.
· Must be proficient in SolidWorks
· Understanding and exposure to
principles of product design, manufacturing, risk
analysis, and product testing/reporting.
· Demonstrated ability to apply
engineering fundamentals and statistical analysis
to manufacturing process trending, improvement and troubleshooting.
· Familiarity with FDA QSR, ISO 13485, and the MDD.
· Excellent communication skills; ability
to work independently or in project team setting.
ABOUT SHIFAMED:
Founded in 2009 by serial entrepreneur Amr
Salahieh, Shifamed LLC is a privately held
medical technology incubator focused on the
development of novel medical products to address
clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
As Shifamed's portfolio of companies continues to
expand, we are looking for creative medical
device engineering talent interested in working
in a fast paced and innovative environment.
Please send resumes to: <mailto:hr_at_shifamed.ocm>hr_at_shifamed.ocm
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Potential applicants should communicate directly
with the contact listed in the posting. Please
do not "reply" to the posting messages.
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Received on 2018-08-08 07:03:07