Description

The Manufacturing Engineer will be integral to all stages of product and process development. This role requires working with and supporting Contract Manufacturing partners. This role will demonstrate a strong ability to collaborate across departments, ensuring seamless integration and execution of manufacturing processes.

Essential Duties & 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. 
• 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. 

Education & Experience:

• BS in an Engineering discipline such as Industrial or Mechanical 
• Minimum of 3 years of experience with medical device manufacturing experience. 
• Can be an equivalent combination of education and professional 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. 
• Ability to sit or stand for up to 8 hours per day. 
• Ability to work on a computer for up to 8 hours per day. 
• Manual dexterity / fine motor skills, if working with precision equipment. 
• Ability to lift up to 20 lbs. 
• Ability to distinguish colors if needed to perform the job.

Salary Range:

$105,000 - $135,000 

Base pay is one part of your total compensation. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, and alignment with market data.

About the company:

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. 

Please note – this is an on-site position. Relocation assistance is not available.

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