Shockwave Medical Careers

Description

•  Work collaboratively with R&D, Quality and Production departments to design, develop, test, validate and implement processes, tooling, and fixtures.
•  Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
•  Perform tolerance analyses for components, manufacturing materials, packaging, and supplies used for in-house processing.
•  Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
•  Participate in development and maintenance of product design FMEAs.
•  Identify requirements, advise Operations management, prepare proposals and implement equipment & fixturing needed for development and manufacturing efforts.
•  Develop and maintain documentation for design control, product configurations (e.g., bills-of-materials), and other Quality System requirements.
•  Lead and/or actively participate in product/process engineering problem resolution.
•  Lead and/or actively participate in process/product improvement projects, Product transfers, line setup, Validation activities (IQ, OQ and PQ) in cooperation with R&D engineers, Quality and technicians
•  Lead the Manufacturing Engineers and Technician and provide them feedback and guidance.
•  Assist Materials, QA and R&D departments with supplier selection and technical development
•  Conduct complex engineering studies and investigations and prepare reports for company leadership
•  Provide engineering guidance to other departments, help to train new engineers and keep abreast of industry trends and issues.
•  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.

•  Bachelor’s degree in Engineering discipline (Mechanical, Biomedical, etc.) or equivalent experience
•  Minimum of seven (7) years of experience in medical device manufacturing.
•  Advanced English
•  Experience with process validations (IQ-OQ-PQ), Lean Sigma, 6S.
•  Strong in Statistics (process capability, CPK, DOE’s, Normality, Hypothesis Testing).
•  Demonstrated proficiency in written and verbal communication, including creating and delivering presentations
•  Advanced skills in critical software applications, such as Microsoft Office.
•  Basic Solidworks Knowledge
•  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 (e.g., traceability QSRs, ISO and MDD requirements)
•  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.