Senior Manufacturing Engineer, Medical Devices & Process Leader

EBR Systems, Inc.; Santa Clara (CA); On-site; USD 123,000 - 158,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid Time Off

Employee stock options

Life & AD&D

Education assistance

Commuter benefits

Weekly lunches

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Root cause analysis

Problem solving

Lean Six Sigma

Process optimization

Cross-functional leadership

Education

BS in Engineering (Industrial or Mechanical)

Tools

SolidWorks

Job description

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