Principal R&D Technician (Ophthalmology)

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 work with R&D Engineers to develop catheter prototypes for ophthalmology and other indications.  The Principal R&D Technician will be responsible for assembling these catheter prototypes as well as being involved in the process development and design improvement of them. In addition, the Principal R&D Technician will work with the R&D engineers in performing bench testing of these catheters, in addition to  maintaining all logs, forms and the resulting paperwork.
 
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 
  • Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation
  • Support the development of test methods and protocols/reports for in-vitro, in-vivo as well as verification and validation testing
  • Responsible for component and assembly documentation for new products being developed
  • 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 
  • 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 a minimum of 8 years’ experience as an R&D Technician in the medical device industry 
  • Knowledge of device design using CAD, material selection and testing
  • Experience in early-stage catheter based cardiovascular devices development is a strong plus
  • Ability to communicate effectively with all cross-functional team members  
  • Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and laboratory practices
  • Machine shop experience is desirable.
  • Proficient with MS Office
  • Ability to analyze and solve problems
  • 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