Senior Manufacturing Engineer

EBR Systems • Santa Clara, CA

6d

About The Position

The Senior Manufacturing Engineer provides technical leadership for manufacturing processes, equipment, and product transfers supporting development, commercialization, and sustaining operations. The role develops, implements, and continuously improves processes to ensure product quality, regulatory compliance, operational efficiency, and scalability. Operating with limited supervision, the engineer independently manages significant projects, 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 position leads manufacturing process development, qualification, optimization, and continuous improvement; establishes process controls, tooling strategies, operating parameters, and validation approaches; and supports manufacturing planning, process capability, efficiency, and compliance. It leads process characterization, design-for-manufacturability efforts, manufacturing transfers and scale-up, production readiness, and technical engagement with contract manufacturers. The engineer also leads investigations into manufacturing issues and implements data-driven improvements to yield, reliability, throughput, and process robustness.

The role defines equipment, tooling, fixture, and automation requirements; leads IQ, OQ, and PQ qualification activities; and supports equipment selection and lifecycle management. It coordinates technical alignment across Manufacturing, Quality, Regulatory, Supply Chain, Operations, and R&D; represents Manufacturing Engineering in reviews; mentors engineering and technician staff; and leads project teams or technical activities as needed. The engineer develops and maintains manufacturing documentation and supports compliance with FDA Quality System Regulations, ISO 13485, internal quality procedures, change control, risk management, process validation, and audit readiness.

EBR Systems develops the WiSE System, a leadless left ventricular endocardial pacing device for heart failure. The company describes its culture as collaborative and transparent, with opportunities for career growth and meaningful work in cardiac technology.

Requirements

• Bachelor’s degree in an engineering discipline, such as Industrial or Mechanical Engineering.
• At least 6 years of medical device manufacturing experience; advanced degrees in engineering, biomedical sciences, or related fields may be considered for reduced experience requirements.
• SolidWorks experience.
• Experience with equipment, tooling, and fixture design.
• Experience with root cause analysis and problem-solving tools for technical and process issues.
• Knowledge of Lean and Six Sigma tools.
• Working knowledge of cGMP requirements for medical device manufacturing under FDA QSR and ISO 13485.

Responsibilities

• Lead development, qualification, optimization, and continuous improvement of manufacturing processes.
• Establish and maintain process controls, tooling strategies, operating parameters, and validation approaches.
• Provide technical support for manufacturing process capability, efficiency, compliance, and planning across development, transfer, launch, and sustaining activities.
• Lead process characterization studies, design of experiments (DOE), and process capability assessments.
• Provide manufacturing expertise during product development, including design-for-manufacturability and scalability.
• Collaborate with cross-functional teams to incorporate manufacturing requirements into product and process designs.
• Lead manufacturing transfers from development to production and between manufacturing sites or contract manufacturers.
• Develop and execute qualification plans, readiness assessments, transfer criteria, and production ramp-up activities.
• Support technical engagement with contract manufacturing partners.
• Lead investigation and resolution of complex manufacturing issues, non-conformances, and process deviations.
• Define corrective actions and risk mitigation strategies for recurring or systemic issues.
• Implement data-driven improvements to yield, reliability, throughput, and process robustness.
• Define requirements and specifications for manufacturing equipment, tooling, fixtures, and automation systems.
• Lead equipment and process qualification, including IQ, OQ, and PQ protocols and execution.
• Maintain manufacturing processes and systems in a validated and compliant state; support capital equipment selection, implementation, and lifecycle management.
• Lead technical alignment across Manufacturing, Quality, Regulatory, Supply Chain, Operations, and R&D.
• Represent Manufacturing Engineering in design, program, and change-control reviews and leadership discussions.
• Mentor engineers, technicians, and cross-functional team members in manufacturing practices and problem-solving.
• Coordinate cross-functional efforts to achieve project and operational objectives.
• Develop and maintain procedures, work instructions, validation protocols, reports, and technical assessments.
• Support change control, risk management, process validation, and audit readiness, and drive consistent engineering, validation, and quality system practices.

Benefits

• 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 and career growth opportunities
• Employee stock options
• Life and AD&D insurance
• Long-term disability insurance
• Education assistance
• Voluntary commuter benefits
• Pet insurance
• Weekly company lunches and occasional happy hour events

What This Job Offers

• Job Type: Full-time
• Career Level: Senior