Principal Manufacturing Engineer
Company: EBR Systems Inc
Posted on: May 14, 2022
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
- Medical, dental, and vision insurance
- Competitive salary with opportunities for career growth
- Employee stock options
- 401(k) Bonus Program
- Life insurance Duties & 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
- 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
- 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. .
Education & Experience:
- BS in an Engineering discipline such as Industrial and
Mechanical or equivalent combination of training and
- Minimum 10 years of experience with medical device
- Minimum 4 years in a medical device manufacturing environment.
- 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
- 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. PI177212338
Keywords: EBR Systems Inc, Sunnyvale , Principal Manufacturing Engineer, Other , Sunnyvale, California
Didn't find what you're looking for? Search again!