Principal R&D Technician (Ophthalmology)

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.

• 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

• 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