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
The Senior Manufacturing Technician will use technical skills to maintain and to support the manufacturing catheter lines that manufacture products to treat peripheral, coronary, and heart valve diseases. The Senior Manufacturing Technician will take part in multiple tasks, such as preforming preventive maintenance and corrective maintenance to manufacturing equipment, operator qualifications via visual inspection, functional testing, and destructive testing. Perform and support a variety of process development and engineering activities, which focus on supporting the catheter manufacturing lines. Will work directly with other manufacturing technicians and manufacturing engineers to complete duties described below.
Essential Job Duties
- Effectively work on multiple project tasks with minimal supervision for timely completion
- Partner with engineers and other technicians to assemble functional prototypes and provide feedback on assembly process and design
- Assist engineers with process design, development, and optimization
- Perform equipment installation and qualification
- Assist in process characterization and process validation testing
- Perform root cause investigation and analysis
- Prepare test samples (products/materials/solutions) for routine and operator qualification testing
- Assist in the transfer of product from manufacturing to manufacturing
- Validate test methods
- Fabrication of fixtures and tooling for product builds and testing (i.e. mechanical, pneumatic, electrical, hydraulic, etc.)
- Preventive maintenance and troubleshooting of manufacturing equipment.
- Create and maintain accurate documentation of concepts, designs, drawings, test methods and processes
- Train other technicians, operators and engineers on procedures and product assembly
- Draft Manufacturing Process Instructions
- Other duties as assigned
Requirements
- High School Diploma required with a minimum of 5 years' experience as a manufacturing technician (or relevant experience) in the medical device industry or Associate's degree with 3 years' experience in the medical device industry.
- Basic knowledge of electricity and electronics, preferred.
- Basic knowledge of machine shop tools, drill press, grinders, band saw is preferred.
- Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and laboratory practices
- Catheter, or other cardiovascular medical devices experience is preferred
- Ability to analyze and solve problems
- Experience using sketches, CAD, etc. to supports the design and build of simple fixtures
- Proficient with MS Office
- 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:
San Francisco Bay Area (SFBA) Market Range: $28.00 - $34.85 per 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