Principal R&D Technician

Research & Development Santa Clara, CA


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.

Description

Position Overview
The Principal R&D Technician will use technical skills in the development of innovative products to treat peripheral, coronary and heart valve diseases. The Principal R&D Technician will participate on multiple cross-functional development teams that manage projects from concept through commercialization. Perform and support a variety of development and engineering activities, which mainly focus on disposable device’s prototyping fabrication and testing. Will work directly with other R&D technicians and R&D engineers to complete duties described below.
 
Essential Job Functions
  • Independently works on multiple project tasks for timely completion 
  • Ability to work with minimal direction and use good judgement and previous experience to bring a concept to reality 
  • Proactively recommends new ideas and/or improvements pertaining to design and process 
  • Lead and mentor other technicians to reach departmental and company objectives 
  • Partner with engineers to design and assemble functional prototypes and provide feedback on assembly process and design 
  • Assist engineers with product and process design, development, and optimization 
  • Initiates root cause investigation and analysis 
  • Perform equipment installation and qualification 
  • Lead product and process characterization and design verification testing 
  • Prepare test samples (products/materials/solutions) for routine and qualification testing 
  • Assist in the transfer of product from R&D to manufacturing 
  • Develop and validate test methods 
  • Design and fabrication of fixtures and tooling for product builds and testing (i.e. pneumatic, electrical, hydraulic, etc.) 
  • Responsible for the maintenance and troubleshooting of lab instruments/equipment 
  • Create and maintain accurate documentation of concepts, designs, drawings, test methods and processes 
  • Train other technicians, assemblers and engineers on procedures and product assembly
  • Develop and draft Manufacturing Process Instructions
  • Other duties as assigned
 Requirements
  • High School Diploma required with a minimum of 10 years’ experience as R&D technician (or relevant experience) in the medical device industry or Associate’s degree with 8 years’ experience in the medical device industry 
  • Previous experience with balloon catheter, drug coating, valve or other cardiovascular medical devices development  
  • Experience using sketches, CAD, etc. to support the design and build of fixtures 
  • Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and laboratory practices
  • Machine shop experience is preferred 
  • Proficient with MS Office 
  • Ability to analyze and solve problems  
  • Comfortable working in a clean room environment. 
  • Ability to communicate effectively with all cross-functional team members  
  • 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 lift objects up to 25lbs

Market Range:

$36.54/hour - $46.39/hour

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: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer