Manufacturing Engineer

The Material Handler manages incoming materials, inventory, and shipments. Responsibilities include, but are not limited to, kit pulling, cycle counting, packaging orders, and maintaining organized work areas. The role also supports safety checks, supply monitoring, and final assemblies, with occasional overtime as needed.

Essential Duties and Responsibilities

• Participate in equipment, fixture, and tooling development projects to increase quality, capacity, reliability, and yields.
• Participate in technical manufacturing projects that improve yield, reliability, manufacturability, capacity, and cost.
• Perform NPI (New Product Introduction) activities as a representative for Operations group that require commercialization phase of new product(s).
• Perform process validation activities that meet regulatory requirements as well as improve process costs and yields.
• Perform process capability assessments and establish methods to control process output.
• Work with the R&D, Regulatory/Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products.

Other Duties & Responsibilities:

• 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.
• Other duties as assigned.

Education and Required Experience

• BS in an Engineering discipline such as Industrial or Mechanical
• Minimum of 3 years of experience with medical device manufacturing experience.

Knowledge, Skills, and Abilities

• Knowledge of CAD and drafting tools. SolidWorks experience required.
• Knowledge of equipment, tooling, and fixture design.
• Working knowledge of root cause analysis and problem-solving tools for both technical and process issues.
• Knowledge of laser micro-welding used in joining small components, and joint reliability testing is a plus.
• Knowledge of Lean and Six Sigma tools.
• Working knowledge of cGMP requirements for medical device manufacturing per FDA QSR and ISO13485.

Physical Requirements:

• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
• Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels.

Disclaimer: EBR Systems Inc. will never ask for personal identifying information (such as Social Security Number, bank account details, or credit card information) during the application process. All communication from EBR Systems Inc. regarding job opportunities will be conducted through official company channels.

EBR Systems, Inc. is an Equal Opportunity Employer committed to a diverse, inclusive, and equitable workplace.

Salary Range

$108,700 - $139,000*

*Base pay is one part of your total compensation. The salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Addition compensation may include bonuses and equity, along with a comprehensive benefits package.

The final starting salary offer to the successful candidate will be determined by evaluating several factors, but not limited to experience, knowledge, skills, internal equity, and alignment with market data.

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.

Company Overview

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 ground-breaking technology to market.

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

• Medical, dental, and vision insurance
• 401K Matching Plan
• PTO - starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• 401(k) Bonus Program
• Life and AD&D Insurance
• Weekly company lunches and occasional happy hour events
• Meaningful work!