Senior Manufacturing Quality Engineer

EBR Systems, Inc. · Sunnyvale, CA · 1 mo ago

Engineering$116k–$156k/yrFull-time

About the role

The Senior Manufacturing Quality Engineer will work cross-functionally with manufacturing teams to drive continuous improvement initiatives. This role is responsible for designing and configuring automated measurement systems. The engineer will serve as a subject matter expert in inspection and test methods, providing daily quality control (QC) support.

Responsibilities

Implement automated measurement systems, establish process monitoring, and lead investigations to reduce scrap, while ensuring adherence to change control requirements.
Author and manage documentation related to test method validation, measurement system analysis, inspection procedures, and risk analysis.
Support production by troubleshooting issues, improving yields, and collaborating with contract manufacturers to resolve quality issues.
Ensure timely closure of non-conforming material reports (NCRs) and adherence to internal procedures.
Lead the analysis of complaint investigations and ensure compliance with quality management systems and regulatory requirements.
Assist in conducting internal audits, maintaining up-to-date technical knowledge, and supervising and mentoring production inspectors.

Qualifications

BS in Mechanical Engineering or Biomedical Engineering.
Four years of related medical device experience.

Skills

Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, and EU MDR.
Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.
Proficiency with software, such as MiniTab, Solidworks, MasterControl.

Benefits