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Staff Manufacturing and Transfer Engineer

Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: November 18, 2021

Job Description:

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 Staff Manufacturing Transfer Engineer will be responsible for management of the contract manufacturer/external partners as well as the implementation and validation of manufacturing lines for Shockwave products. Work closely with cross functional teams to ensure manufacturability, achievement of project, quality & cost targets. Develop manufacturing documentation (specification, drawings) to support build and testing, and directly work with manufacturing/Contract manufacturers/external partners to build prototypes, pilot, and production instruments as appropriate. Troubleshoot and implement changes that improve manufacturing quality and product performance via activities such as historical data and failure analysis, test design, documentation, and validation of equipment and process changes.

Essential Job Functions

  • Act as the primary technical point of contact; work with our Contract Manufacturer/external partner to transfer and scale SW product manufacturing process.
  • Manage development transfer activities between R&D, Product development and operations to contract manufacturer or external partner.
  • Work with local and international suppliers and manufacturing sites to generate capability models and make vs. buy assessments used as an input to site planning.
  • Prepare and execute validation protocols and reports.
  • Prepare engineering change orders and coordinates the implementation of changes including training production staff.
  • Develop and maintain process risk documentation (e.g. PFMEA) and implement preventive and corrective actions.
  • Provide expertise in project planning, timeline development and management. Maintain project schedules and timelines.
  • Monitor product quality and production rates. Ensure capacity is appropriate for the manufacturing plan.
  • Effectively utilize lean manufacturing tools for continuously improve the flow of material and information in the factory including factory layouts, visual management, 5S, JIT, Kanban
  • Develop and implement robust cost-effective manufacturing processes and improves product flow for both sustained and new products.
  • Collaborate with cross-functional teams during development phase(s) and provides inputs and recommendations for design for manufacturability (DFM).
  • Develop, tests, and implements tools, fixtures and equipment required for manufacturing processes.
  • Support production on equipment maintenance, qualification, and calibration.
  • Lead design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control.
  • Assist in product failure investigations and design changes required to improve product reliability and performance.
  • Troubleshoot designs and processes when defects occur, leads investigation to determine root cause and implement effective containment and counter measures.
  • Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.

    Requirements
    • This position may require traveling to Asia up to 30% of the time.
    • Bachelor's degree in Engineering or equivalent experience.
    • 8 years' experience in all phases of Process/Manufacturing development to launch for high volume commercial or medical devices.
    • Proven track record of leading a team and acting as the primary technical interface to a Contract Manufacturer.
    • Strong problem solving and analytical skills; experience with use of statistical analysis and design of experiments for product optimization and validation activities.
    • Working experience with lean manufacturing, design for manufacturing, design for test and test implementation.
    • Proficient in 3D mechanical modeling with SolidWorks.
    • Excellent organizational, verbal and written communication skills as well as attention to details.
    • Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
    • Experience in Program Management, use of Gantt Charts or Smartsheets.
    • Experience with implementing Lean and Lean Sigma concepts.
    • Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.
    • Chinese and or Spanish language proficiency is a plus.

      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

Keywords: Shockwave Medical, Inc., Santa Clara , Staff Manufacturing and Transfer Engineer, Engineering , Santa Clara, California

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