Senior Manufacturing Engineer

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 Senior Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures for throughout the product lifecycle, from design to production. The Senior Manufacturing Engineer will work closely with production, quality, and R&D teams to support the company’s manufacturing operations and product launch timelines. 
 
Essential Job Functions
  • Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures. 
  • Support and work with Quality to address and resolve non-conformances.
  • Collect data and analyze process performance and capabilities for company products, including new products and products already in production. 
  • Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process development and manufacturing efforts. 
  • Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI’s, LHR’s), and other Quality System requirements. 
  • Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology. 
  • Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians). 
  • Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity
  • Assist Procurement and R&D departments with supplier selection and technical development. 
  • Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products, identify and implement cost reduction plans for existing products).
  • 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.
  • Minimum of five (5) years of experience in a medical device environment or, 3 years of experience with a Master’s Degree.
  • Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements)
  • Experience with implementing Lean and Lean Sigma concepts.
  • Experience with Validation of Medical Devices (IQ-OQ-PQ).
  • Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.
  • Ability to use special software such as: Solidworks, Minitab or closely related.
  • 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 occasionally lift objects up to 25lbs.

Market Range:  $113,000 - $138,000

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

EEO Employer

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