Senior Manufacturing Engineer

EBR Systems, Inc.; Santa Clara (CA); Vor Ort; USD 123.000 - 158.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) matching

Paid Time Off

Employee stock options

Life & AD&D

Education assistance

Commuter benefits

Weekly lunches

Zusammenfassung

EBR Systems, Inc. seeks a Senior Manufacturing Engineer to lead manufacturing processes, transfer activities, and continuous improvement for our next‑gen cardiac device program in Silicon Valley.

You will partner with quality, regulatory, and R&D to ensure scalable, compliant production and high product quality. You will own process development, qualification (IQ/OQ/PQ), and equipment selection, mentor engineers, and drive cross‑functional initiatives to improve yield, throughput, and

Qualifikationen

• BS in engineering; 6+ years medical device manufacturing experience.
• Experience with IQ/OQ/PQ and validation in regulated environments.
• Knowledge of cGMP, FDA QSR, and ISO 13485 requirements.

Aufgaben

• Lead development, qualification, optimization, and continuous improvement of manufacturing processes.
• Define and implement process controls, tooling strategies, and validation approaches.
• Lead manufacturing transfers between sites and contract manufacturers.
• Mentor engineers and technicians in manufacturing best practices and problem solving.
• Drive cross-functional initiatives with Quality, Regulatory, and R&D.
• Ensure documentation, compliance, and change control activities.

Kenntnisse

Root cause analysis

Problem solving

Lean Six Sigma

Process optimization

Cross-functional leadership

Ausbildung

BS in Engineering (Industrial or Mechanical)

Tools

SolidWorks

Jobbeschreibung

Description

About EBR Systems

At EBR Systems, we're not imagining the future of cardiac care. We're 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 that's redefining what's possible, and it's just the beginning.

Based in Silicon Valley, we're advancing the WiSE System, a first-of-its-kind device in cardiac rhythm management. Your work here has a direct line to patients whose lives depend on what we build.

We hire people who want to solve hard problems and who care about getting it right. We invest in our people as much as our technology. Expect a collaborative, transparent culture, real career growth in a fast-moving startup, competitive compensation, equity, comprehensive benefits, and generous PTO. If you want your work to matter, EBR is where you belong.

SUMMARY OF THE POSITION:

The Senior Manufacturing Engineer provides technical leadership for manufacturing processes, equipment, and product transfers to support development, commercialization, and sustaining operations. This role is responsible for developing, implementing, and continuously improving manufacturing processes that ensure product quality, regulatory compliance, operational efficiency, and scalability.

The Senior Manufacturing Engineer serves as a subject matter expert for complex manufacturing challenges, leads cross-functional improvement initiatives, and provides technical guidance to manufacturing, quality, supply chain, and product development teams. The role operates with limited supervision and is expected to independently manage significant projects while influencing manufacturing practices and decisions within a product line or manufacturing area.

ESSENTIAL AND OTHER DUTIES AND RESPONSIBILITIES:

Manufacturing Process Leadership

• Lead the development, qualification, optimization, and continuous improvement of manufacturing processes.
• Establish and maintain process controls, tooling strategies, operating parameters, and validation approaches to ensure consistent product quality and performance.
• Provide technical leadership and support to manufacturing operations for process capability, efficiency, and compliance initiatives.
• Support manufacturing planning and process improvements across development, transfer, launch, and sustaining activities.

Product and Process Development

• Lead development and optimization of manufacturing processes to meet quality, cost, delivery, and regulatory requirements.
• Define and execute process characterization studies, DOE activities, and process capability assessments.
• Provide manufacturing expertise during product development to support design-for-manufacturability, scalability, and robust process performance.
• Collaborate with cross-functional teams to ensure manufacturing requirements are incorporated into product and process designs.

Manufacturing Transfer and Scale-Up

• Lead manufacturing transfer activities from development to production and between manufacturing sites or contract manufacturers.
• Develop and execute qualification plans, readiness assessments, and production ramp-up activities.
• Support technical engagement with contract manufacturing partners to ensure alignment with manufacturing and quality requirements.
• Establish transfer criteria and manufacturing readiness requirements for new products and processes.

Sustaining Engineering and Continuous Improvement

• Lead investigations and resolution of complex manufacturing issues, non-conformances, and process deviations.
• Define corrective actions and risk mitigation strategies for recurring or systemic manufacturing issues.
• Develop and implement improvements that enhance yield, reliability, throughput, and process robustness.
• Utilize data-driven approaches to identify and execute continuous improvement opportunities.

Tooling, Equipment, and Validation

• Define requirements and specifications for manufacturing equipment, tooling, fixtures, and automation systems.
• Lead equipment and process qualification activities, including IQ, OQ, and PQ protocols and execution.
• Ensure manufacturing processes and systems remain in a validated and compliant state.
• Support capital equipment selection, implementation, and lifecycle management activities.

Cross-Functional Leadership

• Lead technical alignment activities across Manufacturing, Quality, Regulatory, Supply Chain, Operations, and R&D.
• Represent Manufacturing Engineering in design reviews, program reviews, change control reviews, and leadership discussions.
• Mentor Manufacturing Engineers, Technicians, and cross-functional team members in manufacturing best practices and problem-solving methodologies.
• Coordinate cross-functional efforts required to achieve project and operational objectives.

Documentation and Compliance

• Develop and maintain manufacturing documentation, including procedures, work instructions, validation protocols, reports, and technical assessments.
• Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and internal quality system procedures.
• Support change control, risk management, process validation, and audit readiness activities.
• Drive consistent application of engineering, validation, and quality system practices.

SUPERVISORY RESPONSIBILITIES:

• Provide technical leadership, mentorship, and direction to Manufacturing Engineers, Process Technicians, and Manufacturing Technicians.
• May lead project teams or coordinate technical activities across multiple functional groups.
• Serves as a technical resource and mentor for less experienced engineering staff.
• Does not typically have direct people-management responsibility but may provide project leadership and technical oversight.

QUALIFICATIONS:

• Education and Required Experience:
• BS in an Engineering discipline such as Industrial or Mechanical.
• Minimum of 6 years of medical device manufacturing experience required.
• Advanced degrees in engineering, biomedical sciences, or related fields will be considered for reduced experience requirements.

Knowledge, Skills, and Abilities:

• SolidWorks experience required.
• Experience with equipment, tooling, and fixture design.
• Experience with 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 ISO 13485.

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.

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.

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?

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!

Equal Opportunity Employer Veterans/Disabled