Supplier Quality Engineer I

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Supplier Quality Engineer I performs work with supervision to provide and implement solutions to defined problems and assignments. The scope of responsibilities includes supporting manufacturing operations and working with cross-functional groups to address quality issues. The Supplier Quality Engineer I participates in decisions related to scope of work, process improvements, material disposition, and the implementation of revised product specifications.

Essential Job Functions

• Perform statistical analysis using Minitab or Excel, and document results
• Collaborate with other functional departments on process improvement projects
• Assist Quality Assurance on NCs identified during Incoming QA
• Assist in the planning and scheduling of supplier audits
• Create and release Engineering Reports, and initiate Document Change Orders (DCOs)
• Review, investigate, and disposition Non-Conforming Reports (NCRs)
• Compile, analyze, and summarize supplier performance data for MRs and QBRs
• Other duties as assigned
• Evaluate, procure, and install inspection equipment for the QA Lab
• Create or edit part drawings and assemblies

Requirements

• Ability to work in a fast-paced environment, managing multiple priorities
• Employee may be required to lift objects up to 25lbs.
• Ability to travel up to 10% of the time
• Effective communication skills (verbal, written, presentation)
• Must be proactive and self-motivated
• BS degree in a related engineering discipline with 0-2 years of relevant experience or a Master’s Degree
• Knowledge of statistics, Six Sigma, Lean is a plus
• Knowledge of Quality Systems (eg: cGMP, FDA 820 QSR, ISO 13485) is a plus
• Operate as a team and/or independently

Market Range: $66,581 - $82,500
Exact compensation may vary based on skills, expertise, and location

Benefits

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks -

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer