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Manager, Manufacturing Engineering

Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: January 16, 2022

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 Manager, Manufacturing Engineering leads the efforts of Manufacturing Engineers and technicians in support of day-to-day production and, process and product improvement efforts for the products released from design control (i.e., Phase 5) to market release. Responsible for sustaining engineering, manufacturing and equipment engineering within Shockwave, including designing, developing, testing, and implementing processes for the ongoing production, tooling and fixtures for capacity and productivity improvement. Works closely with product development teams, until successful transfer into the company's manufacturing operations.

Oversees the day-to-day work of employees and manages their performance and development. Develops, implements, and monitors projects, adheres to timelines and budgets, procures capital equipment and tooling as required to support manufacturing efforts, and provides both technical and management leadership to maintain product functionality as well as cost efficiencies.

Essential Job Functions

  • Ensures that Manufacturing Engineering teams deliver the highest quality products using processes which consistently meet (or exceed) all applicable customer expectations; follows QSRs, FDA and ISO requirements; abides by company safety policies, practices and procedures; and consistently meets company goals, objectives, and milestones.
  • Oversees the day-to-day work of Manufacturing Engineering department employees and manages their performance and development by facilitating training and providing performance feedback and guidance.
  • Integrates into cross-functional teams and cultivates a network of support (Manufacturing, Quality, Sales, and Marketing) to facilitate completion of assignments, utilizing external resources as needed.
  • Mediates group conflicts and resolves issues between team members.
  • Participates in and leads continuous improvement activities and advanced problem-solving techniques.
  • Works collaboratively with R&D, Quality and Production departments to design, develop, test, and implement processes, tooling, and fixtures.
  • Collects data and analyze process performance and capabilities for company products, including new products and products already in production.
  • Performs tolerance analyses for components, manufacturing materials, packaging, and supplies used for in-house processing.
  • Leads effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for new company processes.
  • Identifies requirements, advises Operations management, prepares proposals and acquisition arrangements, and implements equipment and fixturing needed for development and manufacturing efforts.
  • Develops and maintains documentation for design control, product configurations (e.g., bills-of-materials), and other Quality System requirements.
  • Leads and/or actively participate in process/product improvement projects (in cooperation with R&D and Quality engineers and technicians). Mentor and Develop Engineers.
  • Performs productivity and costing analyses (e.g., calculate direct labor & materials costs for new products, identify and implement cost reduction plans for existing products).
  • Ensures the engineering team and other manufacturing departments work together cohesively.
  • 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 or equivalent experience.
    • Ten (10) years' of demonstrated management experience in a directly related field, preferably in a medical device manufacturing environment.
    • Ability to manage resources: time, budget and people. Strong people management skills are essential.
    • Experience with process validations (IQ-OQ-PQ), Lean Sigma, 6S.
    • Proficient in statistical analysis (process capability, CPK, DOE's, Normality, Hypothesis Testing).
    • Demonstrated proficiency in written and verbal communication, including creating and delivering presentations to a variety of audiences.
    • Advanced skills in critical software applications, such as Microsoft Office and Solidworks.
    • Expertise in data and problem analysis, creative problem solving and design thinking.
    • Tooling and Equipment design a plus.
    • Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
    • 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.

      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 , Manager, Manufacturing Engineering, Engineering , Santa Clara, California

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