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Senior Manufacturing Engineer
EBR SYSTEMS Sunnyvale, CA
$110k-130k (estimate)
Full Time | Medical Technology 7 Months Ago
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EBR SYSTEMS is Hiring a Senior Manufacturing Engineer Near Sunnyvale, CA

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. The company’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 successful Senior Manufacturing Engineer will directly contribute to the success of EBR Manufacturing through process development, transfer to manufacturing, commercial launch, and sustaining support. Design, procure, and qualify critical tooling, fixtures, equipment, and documentation to achieve high manufacturing quality and efficiency. Provide technical support in solving product non-conformances, as well as realize technical and business opportunities. The Senior Manufacturing Engineer will be involved in manufacturing processes that comprise of passive implantable devices, ultrasound arrays, battery assemblies, electronic assemblies, and catheters.

EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

  • Medical, dental, and vision insurance
  • 401K
  • PTO starting at 3 weeks per year
  • Competitive salary with opportunities for career growth
  • Employee stock options
  • 401(k) Bonus Program
  • Life insurance
  • Weekly company lunches and occasional happy hour events

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 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.
  • Provide production sustaining support such as training, documentation updates, and equipment maintenance/repairs. 
  • Develop and maintain product structure bill of materials.
  • Author and implement appropriate design change orders.
  • Work with Quality Engineers to investigate product/process failures and collaborate on developing immediate and preventive measures.

Requirements

 Education & Experience:

  • BS in Engineering, plus 6 years’ experience in a relevant role, or
  • 8 years in an engineering-related role, including 6 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 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.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Medical Technology

SALARY

$110k-130k (estimate)

POST DATE

08/18/2022

EXPIRATION DATE

01/31/2023

WEBSITE

ebrsystemsinc.com

HEADQUARTERS

SUNNYVALE, CA

SIZE

50 - 100

FOUNDED

2003

TYPE

Private

CEO

JOHN MCCUTCHEON

REVENUE

$10M - $50M

INDUSTRY

Durable Manufacturing

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About EBR Systems

EBR Systems designs and develops implantable wireless tissue simulator for patients with cardiac rhythm disorders.

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