Quality Engineer II

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Supply Chain Engineering

Quality Engineering

Scientific/Technology

Santa Clara, California, United States of America

Employer:

Shockwave Medical Inc.

Job Title:

Quality Engineer II

Job Code: A011.10374

Job Location:

Santa Clara, CA

Job Type: Full-Time

Rate of Pay: $105,000 - $115,000 per year

Develop, apply, revise and maintain quality standards for processing materials/products into partially or finished products. Design and implement methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment. Support manufacturing and work cross-functionally to resolve technical problems. Participate in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications.

Process, investigate, and complete customer complaints. Prepare documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, product defect investigations and inspection plans. Assess if components, sub-assemblies, and products meet specification and can initiate, investigate, and resolve non-conformances by working in conjunction with a multidisciplinary team. Participate in developing the risk management documentation including (Hazard assessment, design trace matrix development, DV&V testing, and FMEA).

Practice company safety, quality policies and procedures and participate in internal/external audits.

Employer will accept a Bachelor's degree in Bioengineering, Biomedical Engineering or related field and 2 years of experience in the job offered or in a Quality Engineer II-related occupation.

Position requires experience in:

1. Medical device industry;

2. Performing failure/ Product Non-conformance investigations;

3. Production line support including non-conformance investigation and product disposition, supporting process changes and process validation activities including IQ, OQ, and PQ;

4. Technical writing skills for investigations, design and process verification and validation protocols and reports;

5. Developing risk management documentation including plans, hazard assessment, design trace matrix development, DV&V testing, and FMEA;

6. Conducting statistical analysis using minitab or equivalent tools for process capability and data normality assessments, analysis of variance, and hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications; and

7. ISO, ASTM, and FDA standards for quality within the medical device industry.

This job posting is anticipated to close on 10/26/2026.

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Subject to the terms of their respective plans, employees are eligible to…