Senior Manufacturing Quality Engineer

EBR Systems, Inc.•Sunnyvale, CA

About The Position

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 include implementing automated measurement systems, establishing process monitoring, and leading investigations to reduce scrap, while ensuring adherence to change control requirements. Additional responsibilities include authoring and managing documentation related to test method validation, measurement system analysis, inspection procedures, and risk analysis. Supporting production by troubleshooting issues and improving yields, collaborating with contract manufacturers to resolve issues, closing non-conforming material reports promptly, and ensuring adherence to internal procedures are crucial. Lead the analysis of complaint investigations and ensure compliance with quality management systems and regulatory requirements. Additionally, assisting in conducting internal audits, maintaining up-to-date technical knowledge, and supervising and mentoring production inspectors are important duties.

Requirements

BS in Mechanical engineer or biomedical engineering.
Four years of related medical device experience.
Can be an equivalent combination of education and professional experience.
Your understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, and EU MDR will enable you to properly audit and monitor suppliers.
Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.
Proficiency with software, such as MiniTab, Solidworks, MasterControl preferred.
Ability to work independently, using good judgment, initiative, and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.
Self-motivated and self-directed; conscientious approach to work assignments.
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.

Responsibilities

Design, configure, implement and maintain automated measurement systems. Includes creation of inspection tooling fixtures.
Develop and execute test methods validation, measurement system analysis protocols and process validation. Generate complex technical written reports, including statistical analysis to justify sample size selection, equivalence, and acceptable error rates.
Author and manage documentation related to test methods, inspection training and procedures.
Deploy process monitoring systems and maintain statistical process control (SPC) practices.
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.
Serve as subject matter expert (SME) for inspection methods for devices manufacturing and purchased components.
Mentor and train inspector technicians to automated inspection systems and inspection good practices aligned with ISO/IEC 17025 principles.
Review and approve Quality Engineering assessments for Document Change Orders (DCOs) and Supplier Change Notices (SCNs).
Define and implement quality improvement projects for EBR and supplier’s manufacturing processes. Work with various departments to ensure timely closure of CAPAs, NCRs, and complaints.
Coordinate cross-functionally to release or place materials on hold when segregated as non-conforming. Document nonconformances, including root cause analysis and corrective actions.
Support the supplier quality management program through supplier monitoring, audits and issues resolution, including supplier corrective action requests (SCARs), operations NCRs and audit findings.
Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost. Proactively solve moderately complex problems at the product level.
Assist with risk analysis activities and maintaining up to date risk management documents.
Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/EU MDR regulations. Adhere to established company Quality System procedures, the Quality Policy, and work instructions.
Maintain state of the art technical knowledge.
Other duties as assigned.

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 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!