Principal Manufacturing Engineer
Company: EBR Systems Inc
Location: Sunnyvale
Posted on: May 9, 2022
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Job Description:
Description:
Silicon Valley-based EBR Systems is dedicated to superior treatment
of cardiac rhythm disease by providing more physiologically
effective stimulation through wireless cardiac pacing. Heart
Failure affects nearly 6 million people in the United States and
more than 25 million globally. Some heart failure occurs due to
conditions that cause the heart chambers to pump in a
desynchronized manner, reducing the amount of blood pumped with
each heartbeat. EBR's patented proprietary Wireless Stimulation
Endocardially (WiSE) technology was developed to eliminate the need
for cardiac pacing leads, historically the major source of
complications and reliability issues in cardiac rhythm disease
management. We are a team of dedicated individuals, driven to
deliver superior treatment of millions of patients suffering from
cardiac rhythm diseases by developing safe, clinically superior,
cost-effective and reliable therapies using wireless cardiac
stimulation. As a fast-paced company, every team member at EBR
makes a big contribution towards our mission. We seek candidates
who are passionate about improving healthcare and motivated to do
the hard and exciting work required to bring a ground-breaking
technology to market. The Principal Manufacturing Engineer will
contribute to all phases of product/process development, transfer
to manufacturing, commercial launch, and sustaining support.
Support transfer and scale-up of manufacturing to Contract
Manufacturing partner(s). Provide technical support as necessary in
solving product non-conformances, as well as realizing technical
and business opportunities. The Principal Manufacturing Engineer
will also help mentor and grow the Manufacturing Engineering
organization through knowledge transfer and experience.EBR Systems
offers a great place to work as well as generous benefits and
growth opportunities:Medical, dental, and vision
insurance401KPTOCompetitive salary with opportunities for career
growthEmployee stock options401(k) Bonus ProgramLife
insuranceDuties & Responsibilities:Lead the design and development
efforts for significant product and/or process changes and
enhancements which reduce defects, improve yields, and lower
product costs.Lead, mentor, and execute technical manufacturing
projects that improve yield, reliability, manufacturability,
capacity, and cost.Create process validation protocols, conduct
process optimization studies, conduct process verifications and
validations, and generate verification and validation reports.Lead,
author and conduct experiments utilizing DOE methodology and other
design tools. Accurately generate complex written reports.Design,
develop, and implement fixtures and tooling to increase quality,
capacity, reliability, and yields.Perform process capability
assessments and establish methods to control process output.Write,
evaluate, and revise manufacturing risk documents such as MVP and
PFMEA's.Work with the R&D, Regulatory/Clinical Affairs, Sales
and Marketing, and Quality Assurance functions to coordinate pilot
production of new products..
Requirements:
Education & Experience:BS in an Engineering discipline such as
Industrial and Mechanical or equivalent combination of training and
experience.Minimum 10 years of experience with medical device
manufacturing experience.Minimum 4 years in a medical device
manufacturing environment.Qualifications:Comprehensive knowledge of
CAD and drafting tools.Ability to work independently, using good
judgment, initiative, and analytical abilities, to accomplish short
and long-range projects, anticipate likely needs, and recommend
actions with minimal direction.Working knowledge of root cause
analysis and problem-solving tools for both technical and process
issues.Knowledge of Lean and Six Sigma tools. Working knowledge of
cGMP requirements for medical device manufacturing per FDA QSR and
ISO13485.PI177212966
Keywords: EBR Systems Inc, Sunnyvale , Principal Manufacturing Engineer, Engineering , Sunnyvale, California
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