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

• Work collaboratively with R&D, QA and Production departments to design, develop, test, document 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 analysis for components, manufacturing materials, packaging, and supplies used for in-house processing.
• Lead effort to develop and maintains process Failure Modes and Effects Analyses (pFMEAs) for company processes.
• Prepare user requirements, technical specifications, and design specifications.
• 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.
• Evaluate existing engineering processes and implements process improvements.
• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
• Lead and/or actively participates in process/product improvement projects (in cooperation with production, R&D engineers and technicians).
• Assist Procurement and R&D departments with supplier selection and technical development.
• Recommend new technologies to improve system performance and reliability. Performs productivity and costing analyses (e.g., calculate direct labor, time studies& materials costs for new and existing products),providing solutions that improve efficiency and scalability for years to come.
• Identify opportunities and implement cost reduction plans for existing products.
• Support the transfer of product lines and the qualification-validation efforts.
• 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 Mechanical/Biomedical Engineering or equivalent experience
• Minimum of eight (8) years of experience in a medical device environment or equivalent experience in other industries (pharmaceutical or automotive) that use the same principles of operation and similar regulations, or 6 years of experience with a Master's Degree.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
• Experience and understanding Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing
• Experience applying statistics and using statistical software, running Capability Studies (Cpk's), and planning and analyzing DOE's.
• Demonstrated proficiency in written and verbal communication, including creating and delivering presentations.
• 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 25 lbs.

Market Range: 127,000 - 150,000
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