Manufacturing Engineer I

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 and Production departments to design, develop, test, and implement processes, tooling, and fixtures.
• Support Process Validation activities in accordance with the Design Control process.
• Perform process characterization of new manufacturing processes, evaluate Design of Experiments data, and make improvements to optimize processes used to manufacture new products.
• Write robust manufacturing process instructions to be used in a production environment.
• Collect data and analyze process performance and capabilities for new products.
• 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.
• 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 and improvement projects (in cooperation with R&D engineers and technicians).
• Assist Materials and R&D departments with supplier selection and component development.
• Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products).
• Support product transfer to additional manufacturing sites, if applicable.
• 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 Biomedical Engineering, Mechanical Engineering, or equivalent experience.
• Between 0-3 years of experience in a medical device environment.
• 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.
• There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Employee may be required to lift objects up to 25lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space.

Market Range: $75,000 - $90,000
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