Senior Manufacturing Engineer

Description

The Senior 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.

Are you curious, creative, and driven? If you are passionate about healthcare innovation, EBR could be the place for you. 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.

Essential duties and responsibilities include, but are not limited to, the following: 

• 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 cross-functionally with R&D, Regulatory/Clinical Affairs, Sales and Marketing, and Quality Assurance functions to coordinate pilot production of new products.
• Develop and author comprehensive validation protocols and technical reports with minimal supervision.
• Act as a key contributor in process development, troubleshooting, and optimization.
• Conduct thorough Root Cause Analysis (RCA) to identify and resolve process/manufacturing/equipment issues effectively

Other Duties and 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.

Required Education, Knowledge, and Skills

• BS in an Engineering discipline such as Mechanical or Biomedical engineering.
• Minimum of 8 year of experience with medical device manufacturing experience.
• Can be an equivalent combination of education and professional experience.
• 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.
• Proficiency in CNC laser micro welding is a plus.
• Familiarity with catheter design and manufacturing processes is beneficial.
• Knowledge of Lean and Six Sigma tools.
• Working knowledge of cGMP requirements for medical device manufacturing per FDA QSR and ISO13485.

Physical Requirements:  

• Willingness and able to travel approximately 5% of the time. Travel may include weekends and overnight stay.
• 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. 

Salary Range

$122,500 - $157,500*

*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.

About the Company

What if your work doesn’t just support innovation—what if it changes lives? 

At EBR Systems, Inc., we are not imagining that future—we are building it. We are the team behind the world’s first FDA approved, leadless left ventricular endocardial pacing device for heart failure. It’s a breakthrough redefining what’s possible in heart care, and it’s just the beginning!

We don’t just create game-changing medical devices—we grow people. Patients come first in everything we do. You will be empowered to solve real problems and to do meaningful work that truly makes a difference.

If you are driven by purpose, excited by challenge, and ready to shape the future of cardiac technology, we want to hear from you. Visit us at https://www.ebrsystemsinc.com/ to learn more—and join us in our work Empowering Physicians, Powering Hearts.

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

• Medical, dental, and vision insurance provided at no cost for employee-only coverage 
• 401(k) matching plan
• Paid Time Off – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life & AD&D and long term disability insurance
• Education assistance
• Voluntary commuter benefits and pet insurance 
• Weekly company lunches and occasional happy hour events
• Meaningful work and much more! 

 Please visit us at https://www.ebrsystemsinc.com/ to learn more about our company. 

Salary : $122,500 - $157,500