Manufacturing Engineer II

Manufacturing Engineering Santa Clara, CA

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Description

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 Manufacturing Engineer II is responsible for providing engineering support to Production. Also responsible for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product.  In addition, the Manufacturing Engineer II will sustain activities on the production line such as raw material, process and equipment issues.  
Essential Job Functions
  • Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
  • Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
  • Coordinate and/or perform functional and destructive testing to support Engineering Reports. Document the results and provide a statistical analysis using Minitab or excel.
  • Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
  • Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents. 
  • Create, maintain and transfer paper Bill of Materials (BOM’s) and Lot History Records (LHR’s) into Item Structures, Work Definitions and electronic LHR’s.
  • Support efforts to resolve Quality related events (NCR, CAPA, Audit Finding) and maintain other Quality System Requirements.
  • Create and release label files used for printing product labels.
  • Create and execute process validation protocols and reports.
  • Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.
 
Requirements
  • Bachelor’s degree in Engineering.
  • 3-5 years of experience in a medical device environment.  
  • Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
  • Understanding of Lean and Six Sigma concepts.
  • Experience with Validation of Medical Devices (IQ-OQ-PQ).
  • Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE’s, Gage R&R) a plus.
  • Able to create and maintain Drawings in SolidWorks.
  • Experience with ERP and MES (Oracle preferred)
  • Ability to work in a fast-paced environment while managing multiple priorities.  
  • Operate as a team and/or independently while demonstrating flexibility to changing requirements. 
  • Employee may be required to lift objects up to 25lbs or more. Employee will be required to work in an air-conditioned Class 8 Cleanroom.   

Market Range: $86,000 - $107,000
Exact compensation may vary based on skills, experience, 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

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