Senior Manufacturing Engineer
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.
- Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
- Support and work with Quality to address and resolve non-conformances.
- Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
- Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process development and manufacturing efforts.
- Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI’s, LHR’s), and other Quality System requirements.
- Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
- Lead and/or actively participate in process/product continuous improvement projects (in cooperation with development engineers and technicians).
- Apply Lean manufacturing principles in production processes to reduce/eliminate waste and increase productivity
- Assist Procurement and R&D departments with supplier selection and technical development.
- Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products, identify and implement cost reduction plans for existing products).
- 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 Engineering.
- Minimum of five (5) years of experience in a medical device environment or, 3 years of experience with a Master’s Degree.
- Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements)
- Experience with implementing Lean and Lean Sigma concepts.
- Experience with Validation of Medical Devices (IQ-OQ-PQ).
- Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.
- Ability to use special software such as: Solidworks, Minitab or closely related.
- 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 occasionally lift objects up to 25lbs.
Market Range: $113,000 - $138,000
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: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer